Telephone-based Diet and Exercise Coaching and Weight Loss
Transcription
Telephone-based Diet and Exercise Coaching and Weight Loss
T H E P ß © Cá] ® IT 0 @ M (g D g IN) © g Weight Control Telephone- Based Diet and Exercise Coaching and a Weight-L •ss Supplement Result in Weight and Fat Loss in 120 Men and Women Larry A. Tucker, PhD Amy J. Cook, MS; Neil R. Nokes, MPH; Troy B. Adams, PhD PURPOSE Abstract Purpose. Determine the effet ts of telephone-based coaching and a xueight-loss supplement on the lüäght and body fat (BF) o/overwäght adults. Design. Randomized, placet o-controlled experiment with assessments at baseline, 2 months, and 4 months. Setting. Community. Subjects. Sixty ovenueight o obese men and 60 overweight or obese women, 25 to 60 years old. Intervention. Eleven 30-mii .ute telephone coaching sessions were spaced throughout the study; the initial conversation lasted 60 to 90 minutes. Supplement or placebo capsules were taken daily over the 17 tveeks. Measures. Weight xuas measured using an electronic scale, and BF tvas assessed using dual energy x-ray absorptiometry. Results. Subjects taking the placebo lost 1.8 ± 3.3 kg of lueight and 0.7 ± 2.2 kg of BF, whereas supplement users lost i tore: 3.1 ± 3.7 kg of wäght (F = 4.1, P= . 045) and 1.7 ± 2.6 kg ofBF (F = 4.4, p = . 139). Partidpants receiving no coaching lost 1.8 ± 3.3 kg of weight and 0.7 ± 2.2 kg of BF, ivhereas adults receiving coaching lost more: 3.2 ± 3.6 kg of )eight(F= 4.8, p= .032) a- id 1.6 ± 2.5 kg ofBF (F = 4.2, p = .044). Adults receiving both the supplement and coach ing had the greatest losses of weight and BF, suggesting an additive effect (F = 3.2, p — 026; F = 2.9, p = .039, respectively), Conclusions. Both treatmen s, coaching and the supplement, viexued separately and in combination, luorked to help subjects lose weight and BF. Adults can be educated and motivated via telef)hone to change behavU rrs leading to weight loss, and a lueight-loss supplement can be included to increase success. (/ m J Health Promot 2008;23[2]:121-129.) Attaining and maintaining a healthy weight has become a significant problem for most adults. This problem is especially prevalent in the United States, where it is esdmated that 66% of adults are overweight or obese.' Overweight and obesity have dramadc health consequences. Adults with a body mass index (BMI) of 25 or greater are considered at risk for developing diseases and morbidides such as hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gall bladder disease, osteoarthrids, sleep apnea, and respiratory problems.^"'' There is also a higher prevalence of endometrial, breast, prostate, and colon cancers among this segment of the populadon. Furthermore, higher body weight is associated with increased all-cause mortality.'^"''''' Clearly, obesity represents a major challenge because it is both a highly prevalent and a highly preventable Key Words: Obesity, We ght Loss, Coaching, Education, Supplement, contributor to morbidity and mortality. Overweight, Prevendon Re; earch. Manuscript format: research; Research purpose: At the workplace, obesity restilts in intervendon tesdng/progra n evaluadon; Study design: randomized trial; Outcome substantially bigher health care costs measure: biométrie; Setdnjj: local community; Healtb focus: nutridon, weight and absenteeism. According to Finkel, skill building/bebavior change; Target populadon control; Strategy: educadoi stein et al.,' the cost of obesity (exage: adults; Target population circumstances: geographic locadon cluding overweight) in a company with 1000 workers is approximately $285,000 annually. Gorsky et al.^ inLarry A. Tucker, PliD; Amy J. Cook, MS; and Nal R. Nokes, MPH, are idth the College of dicate that over the next 25 years Health and Human Performance, Brigham Young University, Provo, Utah. Troy B. Adams, $16 billion will be spent treadng bealth PhD, is with the Department of Health Promotion and Wellness, Rocky Mountain University of problems stemming from overweight Health Professions, Provo, Uta I. women in the United States. Eurther, in a review by Scbmier et al.,'' it is Send reprint reqttests to Larry i . Tttcker, PhD, 237 SFH, Brigham Young University, Provo, UT 84602; tucker@byu.edu. pointed out that health care costs in the workplace are consistently higher 77ii.v ynanuscñpt xtias submitted May 16,2007; rexri.sions xuere requested July 17, September 12, and September 27, 2007; the, among heavy employees compared manuscript xuas accepted for pubtication ictoberB, 2007. with their normal weight counterparts. Copyright © 2008 by American Joumal i Health Promotion, Inc. Further, according to Tucker and 0S90-1111/08/15.00 + 0 November/December 2008, Vol. 23, No. 2 121 Friedman,'" who re\'iewed 10,825 employed adults from numerous workplaces in the United States, obese employees are more than twice as likely to suffer from high-level absenteeism tban lean workers. In a 2-year prospective sttidy incltiding mostly young employees, Tticker and Clegg" showed that obese workers were 1.7 dmes more likely to have high health care costs (>$5000) than nonobese employees. Because the majority of Americans are overweight or obese and the negative conseqtiences of carrying excess body weight are many and diverse, effective health promotion programs designed to help adults lose weight are needed. Numerous invesdgations have shown that alteradons of diet and/or exercise through sundry behavior modificadon interventions can lead to significant weight loss.'^"'* Simply stated, eadng and exercise behaviors infltience body weight, and because these bebaviors are learned, they can be modified. In short, adults who eat less and exercise more typically lose weight. Unfortunately, teaching and motivating adults to change diet and exercise behaviors leading to significant weight loss is a daundng task. Moreover, in a worksite environment, the resources necessary to accomplish such a goal are significant. However, there may be a reasonable solution. Few, if any, studies have evaluated the extent to which periodic coaching over the telephone can be used as an effective weight-loss strategy. Given the wide tise of cell phones, allowing individuals to be connected to a weightloss coach while in almost any environment, and given the fast pace of our society, which limits the amount of free time adults perceive that they have, weight-loss coaching via telephone may be helpful in reducing this big problem. Overweight adtilts who need help losing weight but cannot find dme to attend educational seminars or self-belp workshops or to visit with a coach in person can probably find time to work with a weight-loss counselor over the telephone. This strategy requires less time and travel than personal visits, making it attracdve to many overweight adults and also to worksite health promotion programs, which are often understaffed and low in resources. 122 American Journal of Health Promotion Although it is difficult to argue with the weight-loss success that typically accompanies significant changes in diet and exercise habits, many adults feel that they need extra help.'"'^" As a consequence, many weight-loss supplements have been developed.''•'•^" Unfortunately, the effectiveness of weight-loss supplements is rarely evaluated using sound methods. Although prescription drugs are regulated and mtist be shown to be effective employing the strictest sciendfic invesdgadons, supplements are not regulated and do not require scientific investigadon. Hence, consumer beliefs regarding the effectiveness of most weightloss supplements are probably based more on advertising and anecdotal ddbits than on science and research. Logic suggests that a sotind approach to promoting weight loss among adults would be to combine two weight-loss strategies that approach the challenge from different angles, one based on traditional behavior change methods (only using the telephone to edticate and motivate conveniendy) and the other using a weight-loss supplement to help with the process. Based on this model, the ptirpose of the present study was to evaluate the effectiveness of two interventions on weight and fat loss: personal weightloss coaching via telephone and a weight-loss supplement. Specifically, the objective was to determine the extent to which personal weight-loss coaching and a weight-loss supplement, considered individually and in combination, influence changes in body weigbt and body fat over 2 months and 4 months, compared with placebo use and no weigbt-loss coaching, employing a randomized, experimental design. A secondary objective was to determine the extent to which gender played a role in the effecdveness of the telephone coaching and the supplement. METHODS Design The study was a placebo-controlled, randomized experiment lasdng 17 weeks. Participants were assessed at baseline, after 2 months, and after 4 months to allow the first-half and second-half effects of the treatments to be evaltiated, as well as the effects over the full 17 weeks. A 2 (supplement: yes/no) X 2 (coaching: yes/no) X 2 (gender: male/female) X 3 (dme: baseline/midtest/posttest) factorial design was employed. Randomization was stradfied or blocked to afford equal numbers of men and women in each experimental condidon. In short, the 128 pardcipants were split into two groups based on gender, 64 men and 64 women, and then the men and women were randomly assigned separately to the two different treatments, active stipplement or placebo, and coaching or no coaching, using a random ntimbers table. Of tbe 128 subjects in tbe invesdgadon, 64 were assigned to the supplement group (32 men and 32 women) and 64 were assigned to the placebo grotip (32 men and 32 women). One-half of those in the supplement group also received personal weight-loss coaching, and one-half received no coaching. Likewise, one-half of those in the placebo group received coaching, and one-half did not. At the outset, there were 32 randomly assigned stibjects (16 men and 16 women) in each of the four experimental condidons: active stipplement with coaching, active supplement with no coaching, placebo with coaching, and placebo with no coaching. Subjects were blinded to the supplement/placebo condition. For tbe telephone coaching condidon, those who received weekly coaching obviously knew they were being coached; however, stibjects not receiving coaching were not aware that a coaching condition existed. The no-coaching subjects believed that the study was only evaluating a weight-loss stipplement. In this way, subjects not receiving coaching did not feel cheated or resentful because tbey were not receiving one-on-one help to lose weight. Sample Subjects were recruited using newspaper advertisements covering approximately 25 cities surrounding a university in the Mountain West. All subjects completed a questionnaire that requested information on their medical histories and lifestyle behaviors. Inclusion criteria included: age of 25 to 60 years, BMI betwe en 25 and 35 kg/ill'^, regular access to . telephone, and self-reported g id health other than being overweight or obese, Subjects were excluded fron the sttidy if they currently smoked or lad quit smoking in the previous 6 njonths, if they had lost 4 or more kg cf 1 body weight in the previous 3 mo iths, if they were pregnant or iinten ied to become pregnant during th( study, if they reported drtig or alcoh (I abuse, or if they reported having a ignificant disease, such as cardiovascular renal, hepadc, endocrine, gastroin estinal, or psychologic, including eadn disorders. All subjects indicated t leir willingness to pardcipate in the study by signing a consent form whicl had been approved by the univeisity Ir sdttidonal Review Board. Subjects were not paid to pardcipate in tbe study, but they were given a certificate allov ing them to participate for free lor 3 nonths in tbe weight loss clinic of the tiniversity Wellness program after compl eting the study, if they desired. Measures Dtial energy x-ray absorpti ometry (DEXA; 4500W; Hologic In , Bedford, MA) was used to meastire the body fat of each pardcipant in grams. The 4500W is the same DEXA model tised in the ongoing government- ponsored Nadonal Health and Nutridon Examination Stii"vey. Concurrent vilidity of the 4500W DEXA machine t sed in the present study was established by comparing tbe DEXA body fat re: tilts to the body fat findings produced by the Bod Pod' employing 100 adults. The Pearson correlation between the two measures of body fat was 0.94 (/> < .0001), and 0.97 {p < .0001) for th( intraclass correlation.'^' A test-retest evaluation using the same 100 adults and complete repositioning of each ; tibject resulted in an intraclass coneladon of 0.999 (/; < .0001), indicadng that the 4500W was extremely reliabl Body weight was meastired to the nearest 0.005 kg (0.01 lb) using a Profit electronic digital scale (Life; ource, Milpitas, CA). Calibradon w; s checked daily before data collecdon tsing known weights. Test-retest results using all subjects of the present stidy resulted in an intra-class correladon of Stamped, addressed envelopes were given to stibjects so that they could mail in their completed logs at the end of the first and third months of the sttidy. Subjects were instructed to bring tbeir latest logs with them to the 2- and 4-month assessment visits. The logs were tised to calctilate supplement/ placebo compliance. Subjects were contacted by telephone each month to remind them to mail in their logs or to come to their assessment appointments. Stibjects were given enough of the supplement or placebo to last 8 weeks (i.e., undl their midtest assessments). At the conclusion of their midtest visits, subjects were given additional botdes to last them undl the conclusion of the study. 0.999 {p < .0001), showing excellent reliability. Weight-loss Supplement Tbe sttpplement, used to help subjects lose weight, was formtilated by TriVita, Inc (Scottsdale, AZ). The supplement and placebo were provided free to pardcipants and were packaged in idendcal sealed bottles. Reseaicbers at all levels, coaches, and participants were blinded to which botdes contained the active supplement and which contained the placebo. The codes showing which stibjects received the supplement and which received the placebo were held by a third party undl all data were collected. Botdes were idendfied with subject numbers. One-balf of the subjects were given botdes containing the acdve supplement, and one-haíf received the placebo. Stibjects were instructed to take four capsules daily, two in the morning and two in the evening, preferably witb meals, and to record tbeir supplement/placebo tise on a printed log. Supplement Mechanisms of Action Each capsule contained 700 mg of supplement, and the fotir capsules together inclttded the following: vitamin B| (15 mg), vitamin Bg (10 mg), niacinamide (SO mg), vitamin B5 (50 mg), \'itamin Bf, (2 mg), xntamin B|¡; (1 mg), biodn (2 mg), vitamin C (22.5 mg), vitamin D (1000 IU), dimethylglycine (100 mg), chromium (0.05 mg), copper (0.5 mg), magnesitim (200 mg), vanadyl sulphate (1 mg), manganese citrate (1 mg), zinc glticonate (10 mg), indium sulphate (25 mg), Cardnia cambogia (250 mg), Gymnema sylvestre (10:1; 100 mg), bitter melon (10:1; 70 mg), cinnamon bark (500 mg), Poria cocos (5:1; 100 mg), Rhizoma zingiberis (4:1; 50 mg), green tea (10:1; 100 mg), Korean ginseng (100 mg), L-theanine (50 mg), gamma-aminobtityric acid (50 mg), alpha lipoic acid (110 mg). Calcárea carbónica (12X; 10 mg), na- trum stilphuricum (12X; 10 mg), graphites (30C1; 10 mg), nux vómica (30C; 10 mg), lycopodium (30C; 10 mg), and glucomannan (700 mg). The placebo was formulated to look like the supplement but witb no active ingredients. The same dosage was used for the supplement and the placebo. The formuladon of the supplement was designed to primarily focus on improving glycémie control, increasing metabolism, enhancing mood, and decreasing appedte, collecdvely leading to the goal of weight loss. The mechanism of acdon of each acdve ingredient is listed below. Research shows that an extract of G. cambóla, hydioxycitric acid, redtices food intake and body weigbt regain, presumably because of its inbibidng effect on lipogenesis.'^'^ Otber research has fotmd that G. cambogin inhibits cytoplasmic lipid accumuladon as well as adipogenic diffeiendadon of preadipocytes, and it inhibits expression of an early adipogenic tianscripdon factor that regulates adipogenesis.'^'' G. .sylvestre extracts have antihyperglycemic properdes that may help to reduce appedte.''^'^••^'' The andhypeiglycemic properties of G. sylvest.re are dtie to a combinadon of two mechanisms. G. sylvestre increases the acdvity of enzymes responsible for glucose uptake and udlizadon, and it inhibits peripberal udlizadon of glucose by somatotropbin and cordcotrophin.'^'' Extracts of bitter melon have been sbown to normalize blood glucose levels and reduce triglycéride levels.'•*' Research indicates that bitter melon juice leads to a redtiction in visceral fat and slower weight gain in rats, partly due to enhanced sympathetic activity and lipolysis.^" November/December 2008, Vol. 23, No. 2 123 Using a type 2 diabetic animal model, Kim et al.^'^ found that cinnamon bark extract has a regulatory role in blood glucose and lipid levels and may also exert a blood glucose-suppressing effect by improving insulin sensitivity or slowing absorpdon of carbohydrates in the small intesdne. P. cocos is a type of mushroom. Numerous polysaccharides and polysaccharide-protein complexes have been isolated from P. cocos and used as sources of therapetidc agents.™ Among other therapetidc properdes, polysaccharides have glucose-regulating activides, and pharmacologie research indicates that pancreadc dssues may benefit from these polysaccharides. They may also increase insulin output by beta cells, increasing the availability of insulin and facilitating the metabolism of insulin-dependent processes, which are associated with weight reguladon and fat deposition.^' Green tea contains both tea catechins and caffeine and acts through the inhibidon of catechol O-methyltransferase and inhibition of phosphodiesterase.^^ Tea catechins have antiangiogenic properties that may help to prevent the development of overweight and obesity.''^ Research has showed that green tea supplementation promotes weight loss.*' Korean ginseng may be beneficial in weight management by improving blood sugar control.'''* In a study using hyperglycémie rats, ginseng extract was found to exert its antilipolytic effects through a signaling pathway different than that of insulin.'''' L-theanine is a nonprotein amino acid found naturally in the green tea plant. Camellia sinensis?^ L-theanine crosses the blood-brain barrier and increases both serotonin and dopamine production, which tend to lower blood pressure and improve mood.'"" Given that some adults eat to relieve feelings of stress, it is postulated that L-theanine may help with this problem. Alpha lipoic acid enhances glticose uptake in type 2 diabetes and inbibits glycosyladon. Besides blood sugarregulating properdes, alpha lipoic acid also appears to possess weight-regulating properties, exerting these effects in the hypothalamus by suppressing appedte by inhibidng AMP-activated protein ''^ 124 American Journal of Health Promotion Vitamin D is both a vitamin and a hormone. It is a vitamin because the body cannot absorb calcium without it; it is a hormone because the body manufactures it in response to the skin's exposure to sunlight. Vitamin D significantly increases the absorpdon of calcium.^' Dietary calcium appears to play a role in the regulation of energy metabolism and obesity risk.''* One study showed that 80% of morbidly obese patients presented with vitamin D deficiencies.''^ High calcitim diets seem to attenuate body fat accumuladon and weight gain during periods of overconsumption of an energydense diet and to increase fat breakdown and preserve metabolism during caloric restricdon, thereby accelerating weight and fat loss. This effect is mediated primarily by circulating calcitriol, which regulates adipocyte intracellular calcium.'"^ Chromium polynicodnate is an essential trace mineral that helps the body maintain normal blood sugar levels.'"' Chromium has been studied extensively regarding weight and fat loss. Although findings are far from unanimous, results show that chromium supplementation tends to slow weight gain and aid in weight loss."*' Glucomannan is a water-soltible dietary fiber that is derived from the konjac root. Like other forms of dietary fiber, glucomannan is considered a "bulk-forming laxative.'"*^ Research has suggested that glucomannan may promote weight loss.'*'^"'*' The evidence suggests that glucomannan exerts its effects by promodng sadety and fecal energy loss, and possibly by improving glycémie status.''^ Personal Weight-loss Coaching The weight-loss coaching intervention included talking on the telephone with a trained weight-loss coach once per week for approximately 30 minutes per session during at least 11 of the 17 weeks of the study. However, the inidal telephone coaching session was scheduled to last 60 to 90 minutes for the participant and coach to get to know each other and to allow time to btiild a meaningful foundation from which to work. During the initial 6 weeks of the study, subjects were encouraged to pardcipate in weekly coaching sessions; during the final 11 weeks, subjects were asked to work with their coach every other week. If a stibject reqtiested an addidonal coaching session, then an extra session was added, however, subjects were not coached more than once in any week. Sessions were arranged to accommodate subjects' schedules, although most sessions were held at the same dme and on the same day of the week across the study. Subjects were encouraged to make up missed sessions as soon as possible. The TriVita personalized health coaching service was the foundadon of the coaching intervention. Three weight-loss coaches were used in the study. Stibjects were cotinseled by the same weight-loss coach throughotit the entire study. Each of the three coaches was cerdfied through the WellCoaches program,'"' which is endorsed by the American College of Sports Medicine. During the telephone coaching sessions, weight-loss guidelines developed by the American College of Sports Medicine were used to assist stibjects.'" In short, subjects were taught abotit the energy balance model and the importance of expending more energy than was constimed. They were educated to practice self-monitoring and were trained to become more aware of their eadng habits and energy needs. Pardcipants were encotiraged to consume healthy meals; avoid extreme diets; eat smaller pordons; consume more fruits, vegetables, and fiber; reduce junk food consumpdon; and exercise more. As subjects pardcipated in the program, specific weight-loss problems and barriers tbat surfaced were discussed during coaching sessions, and possible soludons were provided. As mtich as possible, weight-loss strategies and diets were customized to fit the needs and interests of each participant. Moreover, each telephone coaching session served as an opportunity for participants to report back to their coaches about successes and failures and to be accountable for their behaviors. Subjects in the weight-loss coaching group were asked to keep written logs of their coaching sessions in addidon to their supplement or placebo use. The same log was used for recording both intervendons, and the logs were returned via mail or in person so that compliance could be monitored. Analyses The PASS power analysis Software (version 6.0; NCSS, Kaysville, UT) was used to calculate the sampk size necessaiy to conclude the in /esdgadon with a minimum power of 0 80 and an effect size of 0.25. Addidond subjects were incltided in the sample to allow for a combined attrition anc noncompliance rate of 25% (actual tttrition and noncompliance together was approximately 10%). Repeatec-measures analysis of variance (ANOVA) was used to identify the effects of supplement use compared with placebo ase, tbe effects of weight-loss coaching compared with no coaching, anc the effects of gender on body w ;ight and body fat across tbe three dn e periods of the 4-month study. The effect of gender was considered secondary, and because there were no gend;r differences and gender had no effect on any of the other relationships, the female and male data were pooled ; ind the gender factor dropped from the analyses. Because the invesdgadon ncltided a pretest, midtest, and posttest to enable evaluation of the short-term effects of the treatments, as veil as the longer-term effects, the data were analyzed across the first and second halves of the study separately, as well as across the endre study. Pard il correladon was employed to determine the extent to which group mem jership in the second treatment infltieiiced the treatment effects. The least-s^quares means procedure was emplo^ied to calculate means adjusted for differences in the potential confo lnding variables. All analyses were performed with SAS software (version 9 1; SAS Insdtute Inc, Cary, NC). An intent-to-treat strategy vas also used with all subjects who b( gan tbe study included in the analyse s ( n = 128). In short, pardcipants who dropped out of the study an i those who failed to comply with th supplement/placebo and coaching nocoaching protocols were included. RESULTS Participant Characteristics Of the 120 subjects who completed the study, 60 were men and 30 were women. Additionally, approximately 95% of the sample was white, with the remaining participants repordng Asian or Hispanic ethnicity. At baseline, the average age was 43 ± 9 years and ranged from 25 to 60 years. At baseline, the mean body weight of the sample was 91.3 ± 14.5 kg, average percent body fat was 35.8% ± 6.1%, and mean BMI was 30.6 ± 2.7 kg/m'"^. There were no significant differences among any of the treatment groups on any of the outcome variables at baseline, indicadng that random assignment of subjects to groups was successful. Compliance A total of 120 of the 128 (94%) original participants completed the baseline, 2-montb, and 4-month assessments. Reasons for quitting the study included loss of interest (five subjects), pregnancy (one subject), divorce (one subject), and serious automobile accident (one subject). None of the dropouts reported any ailments or side effects that might have been associated with taking the supplement/placebo. Stibjects were required to record their supplement or placebo use each day on preprinted forms. The written logs were used to identify subjects wbo did not take tbeir capsules on a regular basis. Subjects wbo reported less tban 70% compliance over the 4-month sttidy were not incltided in the analyses. Of the 120 subjects who completed the sttidy, five were identified as noncompliant because of tbeir infrequent supplement use, leaving 115 subjects (90% of the original sample) for the supplement/placebo analysis. Average supplement use compliance was 88% ± 12% witb noncompliant subjects removed. Records were also kept of each telephone coaching session. Over the 17 weeks of the study, subjects in the coaching group who did not participate in at least 11 coaching sessions were considered noncompliant and were dropped from the analyses. Of the 60 subjects in the coaching group who completed the sttidy, seven failed to meet the 11 coaching session minimum, leaving 113 subjects (88% of the original sample) in the coaching/nocoaching comparison. Average number of coaching sessions per subject in the coaching group was 11.6 ± 0.7 over the 17 weeks among subjects who were compliant. Effect of the Supplement At baseline, there were no differences between the supplement and placebo groups in body weight (F = 1.3, p= .266) or body fat (7'^ = 0.1, /; = .818). However, tbe group by time interacdon of the repeated-measures ANOVA indicated that subjects in the active supplement group lost significantly more weight (F = 4.2, p = .016) and body fat (F = 4.5, p = .013) than participants in the placebo group over the three assessment periods (Table 1). Specifically, adults who took the supplement lost 1.3 kg or 76% more body weigbt and 0.9 kg or 132% more body fat than their counterparts over the 4-month study duration. After controlling for membership in the coaching/no-coaching groups (i.e., the second treatment), we noted that differences in body weight {F = 4.3, /; = .040) and body fat (F = 5.2, /; = .025) remained unchanged and significandy different between supplement and placebo users. Mean differences in weigbt {F = 6.6, p= .011) and body fat {F = 7.8, p = .006) were also significant between the supplement and placebo groups after the first 2 months of the study. During the first half of the study, supplement users lost 1.3 kg more or twice the body weight and nearly 1 kg more or 2.3 times the body fat compared with placebo users. However, differences between the supplement and placebo users in body weight (F = 0.0, /; = .865) and fat (F = O.\, p = .793) were not significant over the last 2 months of the study. Using an intent-to-treat strategy, including all subjects who dropped out of the study and all subjects who completed the study but did not take tbe supplement regularly (noncompliers), weakened the treatment effect. Specifically, repeated-measures ANOVA across the baseline, midtest, and posttest were borderline significant, showing that subjects in the supplement grottp lost more body weight {F = 2.4, p = .091) and more body fat (F = 2.7, p = .073) than those in the placebo group. Further, with all dropouts and noncompliant subjects in- November/December 2008, Vol. 23, No. 2 125 Table 1 Effect of the Supplement and Coaching Viewec1 Separately on Weight and1 Body Fat Across the Baseline, Midtest,and Posttest Baseline Body Weight (kg) Midtest Body Weight i(kg) Posttest Body Weight (kg) Treatment Mean SD Mean SD Mean SD F* P Supplement Placebo Coaching No coaching 89.7 92.7 91.8 91.1 Baseline BF (kg) 13.7 14.9 14.5 14.9 87.2 91.4 89.4 89.7 Midtest BF (kg) 13.6 14.9 14.6 15.2 86.6 90.9 88.6 89.3 Posttest BF (kg) 14.0 15.0 14.6 15.7 4.2 0.016 3.9 0.022 Supplement Placebo Coaching No coaching 28.8 30.1 29.4 29.6 4.8 5.2 5.1 5.3 27.6 29.7 28.4 29.0 5. 2 5..4 5..4 5..7 27.2 29.4 27.8 28.9 5.8 5.2 5.5 5.9 4.5 0.013 3.4 0.036 SD indicates standard deviation; and BF, body fat. * F represents the F ratio for the group by time interaction for the two treatments viewed separately (i.e., supplement vs. placebo, coaching vs. no coaching) across the three time periods. There were 53 subjects in the supplement group and 62 in the placebo group (n == 115). There were 53 subjects in the coaching group and 60 in the no coaching group (n = 113). eluded in the analyses and controlling for membership in the coaching/nocoaching grotip (i.e., the other treatment), we found that stipplement users lost significantly more body weight (2.1 ± 2.8 kg) than placebo users (1.2 ± 2.4 kg) during the first half of the study {F = 3.9, p = .049). The difference in body fat loss between the supplement (1.0 ± 1 . 7 kg) and placebo (0.4 ± 1 . 6 kg) groups during the first 8 weeks was also significant {F = 4.8, p = .031) using the intent-totreat approach. Effect of the Coaching There were no differences between the coaching groups in body weigbt {F = 0.1, p = .802) or fat (7-^ = 0.1, p = .749) at baseline. Eurther, there were no differences in weight loss {F = 1.65, p = .201) or fat loss (F= 0.8, p = .460) resulting from the three different coaches among participants; therefore, the coaching data were pooled. Repeated-meastires ANOVA indicated that participants in the coaching group lost significandy more body weight (F = 3.9, p = .022) and fat {F = 3.4, p = .036) than those in the no-coaching group over the three assessment periods (Table 1). Specifically, coached adults lost 1.4 kg or 78% more body weight than uncoached pardcipants and 0.9 kg or 122% more body fat than their counterparts. With the effect of supplement/placebo use controlled (i.e., the second treatment), the difference in weight loss between the 126 American Journal of Health Promotion coaching and no-coaching groups was reduced by 0.19 kg and the results became borderline significant (/; = .068). Although losses in body weight and body fat between the coaching and nocoaching groups were significant when viewed across the three assessment periods (Table 1), body weigbt changes between the two grotips during the first 2 months or first half of the study {F = 3.4, p = .067) and body fat changes during the last 2 months or second half of the study were borderline significant {F = 3.1, / ; = .080). The intent-to-treat approach weakened the effect of the coaching intervention. Across the three time periods, adults who received weight-loss coaching did not show greater weight loss (F= 1.9, p = .149) or body fat loss (F = 2.0, p = .143) compared with those who received no coaching. Similar results were revealed for differences in weight loss {F = 1.6, p = .214) and fat loss {F = \.%p= .268) during the first 8 weeks of the study, after adjusdng for membersbip in the stipplement/placebo group. Effect of the Supplement and Coaching Comhined The combined effects of the two treatments are presented in Table 2. Viewed as four separate groups or conditions, there were significant differences in weight loss {F = 3.2, p = .026) and fat loss (F = 2.9, /; = .039) over the 4-month sttidy. Restilts showed that stibjects who received both the active stipplement and personal weight-loss coaching over the telephone had greater body weight and fat losses compared with each of the other groups. None of the other groups differed significantly from each other over the study. When the analysis was limited to the first half of the study, similar findings resulted. Specifically, the acdve supplement -H coaching group lost significandy more weight (/''= 3.6, p = .017) and body fat (F = 3.6, p = .016) than each of the other grotips. However, during the second half of the sttidy, there were no significant differences in weight loss (F = 0.8, p = .485) or fat loss {F= 1.0, /; = .383) among the four groups. DISCUSSION According to the results, botb treatments helped subjects lose significant body weight and body fat, viewed separately and in combination. Specifically, regtilar use of the weight-loss supplement resulted in greater body weight and body fat losses compared with placebo use. Most of the benefits derived from taking the supplement stirfaced within the first 2 months of the study. During the first 8 weeks, supplement users lost twice the body weight and 2.3 dmes more body fat compared with placebo tisers. Research has indicated that early weight loss is a strong predictor of Table 2 Effect of the Supplement and Coaching Treatments Combined on Weight and Body Fat Four Combined Treatment Conditions Supplement Coaching Supplement + no Coaching Placebo + Coaching Placebo + no Coaching Outcome Mean SD Mean SD Mean SD Mean SD F P Weight loss* (kg) Fat loss* (kg) 4.4t 2.3t 3.5 2.7 2.3t 1.3t 3.5 2.2 2.1t Lit 3.5 2.3 1.7t 0.4t 3.2 2.2 3.2 2.9 0.026 0.039 SD indicates standard deviatio n. * Weight loss and fat loss refk ctthe average number of kg lost from baseline to the posttest 17 weeks later. t, t Means in the same row w th the same symbol are not significantly different (p > 0.05). success in weight-loss progrims."' Early weight loss builds conf idence and engenders hope concerning future weight loss. Given the rapid weight loss resulting from use of the st pplement. it follows that the supplement would be valtiable in jtimp-starting weight-loss efforts, thereby increasing s access in weight-loss programs. There were no significan! differences in weight or fat loss hetween supplement and placebo usîrs during tbe second half of the sttid). Apparendy, the supplement pronioted significant weight loss during ihe first 8 weeks, after which its influence diminished. Although the actual cause is unknown, it is possible that subjects adapted physiologically to tlie supplement, becoming less sensiti"e to its ingredients, making it less effective over time. According to the findings, one-onone coaching over the telep hone also resulted in significant weight and body fat losses in men and women. However, unlike the effects of the supplement, weight loss due to coaching was less front-loaded and more bala iced over the endre investigadon. In ihort, coaching helped subjects lo ;e weigbt and fat over tbe 4-month study, but it did not have a significant eflect during the first 8 weeks like the supplement did. Numerotis investigations f ave shown that health coaching works.'""''^ Research has indicated that the coaching strategy has helped type 2 d abedcs," increased fitness pardcipadc n,'''' supported lifestyle changes,'^•'^ improved diet and food choices,'''' ma aged stress,'^'' enhanced mental health,''''^ and lowered health care costs.''' Although rare, telephone coaching has also been used in one case to improve diabetes care.™ However, to date, few, if any, invesdgations have studied the extent to which coaching over the telephone is a worthwhile weight-loss strategy. Because cell phone use has become commonplace, allowing the ovei"weight to communicate with weight-loss coaches in almost any setdng, and because we live in a fast-paced society, limidng time to meet with health professionals, telephone coaching designed to help with weight loss seems to be a commonsense soludon. Obese individuals who need assistance losing weight btit feel too busy or too shy to meet one on one may be able to find dme to work with a weight-loss coach over the telephone. Less time and less travel are required compared with attending meetings and personal visits, making telephone coaching valuable to many adults. In tbe present study, tbe stipplement and coaching were effective in producing significant weight loss in men and women. However, the two strategies worked better in combination than individually, displaying an additive effect. Specifically, adults who took the supplement and received coaching lost almost twice the weight and body fat compared with those who took the supplement btit received no coaching or those who received coaching but took tbe placebo. In short, the two weight-loss strategies, supplement use and telephone coaching, best promote weigbt loss when used together. Although there are several possibilities, the positive combined effects of the supplement and coaching may be pardy a funcdon of the dme-course benefits of each treatment. The supplement had its greatest impact early in the study, likely ctirbing appedte while new behaviors were being adopted. Later, as the effect of the supplement diminished, behavior changes restilting from coaching condnued to help with additional weight and fat los.ses. Using the intent-to-treat approach for the data analyses weakened the effects of the treatments, especially lor telephone coaching. Using the intentto-treat strategy, eveiy stibject who began the study was included in the analyses, even those who dropped out and those who did not comply with the assigned protocol. Although this approach is commonly tised to protect against biases tbat may lestilt from dropouts and noncompliance, the intent-to-tieat method may not be a good analysis strategy given the purpose of the present study. Combining subjects who should have taken the stipplement but did not with those who took the stipplement and combining stibjects wbo should have received telephone coaching but did not with those who pardcipated in the coaching inteiA'endon may introduce more bias into tbe study than it prevents. In this study, the goal was to determine the direct effect of the supplement and telephone coaching on weight loss. It is doubtful tbat tbe effect of tbese treatments can be determined if subjects who did not receive the treatment, whether because of qtiitdng the sttidy or not complying, are combined with subjects who received the treatment. True, the effect of a program. November/December 2008, Vol. 23, No. 2 127 designed to use these treatments can be evaluated using the intent-to-treat approach, but it is unlikely that the direct effect of the supplement and coaching interventions can be measured using this strategy. The intent-totreat approach was included for those who favor this method of analysis. Strengths of the present study included a large sample size, random assignment of subjects to groups, equal number of male and female pardcipants, low dropout rate, use of a placebo and double-blind strategy for the supplement, body fat changes measured using DEXA, and three assessment periods over the duration of the investigadon. Weaknesses included little ethnic diversity and a 4-month study duration. CONCLUSION Approximately two in every three American adults are overweight or SO WHAT? Implications for Health Promotion Practitioners and Researchers The present study indicated that regular weight-loss coaching over the telephone can be used to help overweight and obese adults lose significant amounts of weight and body fat. Given the prevalence of obesity in the workplace, telephonebased weight-loss coaching may allow obese employees to work with weight-loss coaches without having to leave work or travel. Also, given the number of adults who carry cell phones, this weight-loss strategy may encourage greater contact between individuals striving to lose weight and weight-loss coaches. The current investigation also showed that a weight-loss supplement can be used to jump-start the weight-loss process and facilitate reductions in body weigbt and fat in overweight and obese adults. Together, the two intervendons may be useful in helping to curb the costly and growing problem of obesity. Future research is needed to identify other strategies that can be employed to assist individuals who have limited time but need help in fighting obesity. 128 American Journal of Health Promotion obese. The cost associated with overweight and obesity in the workplace is substantial. Although there are a variety of programs that can be employed to assist with weight loss, many have not been studied using sound research methodologies. The two weight-loss treatments evaluated in the present study, a weight-loss supplement and diet and exercise coaching via telephone, appear to be effective weightloss interventions. When used separately, their benefits are significant. When used in combination, their weight-loss effects double. Acknowledgments Wi thank the partidpants of this study for their cooperation. This study xuas funded by a research grant from TriVita, Inc. References 1. 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