Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss.
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ABSTRACT:
SUBMITTER: Shikany JM
PROVIDER: S-EPMC3836833 | biostudies-literature | 2013 Dec
REPOSITORIES: biostudies-literature
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Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss.
Shikany J M JM Thomas A S AS Beasley T M TM Lewis C E CE Allison D B DB
International journal of obesity (2005) 20130409 12
<h4>Objective</h4>The Medifast 5 & 1 Plan (MD) is a portion-controlled, nutritionally-balanced, low-fat weight-loss plan. We studied the effects of MD compared with a reduced-energy, food-based diet (FB) on body weight, waist circumference, fat mass and other measures in adults.<h4>Design</h4>We conducted a two-parallel-arm, randomized, controlled trial comparing MD to FB over 52 weeks. A total of 120 men and women aged 19-65 years with BMI 35 and 50 kg m(-2) were randomized to MD (n=60) or FB ...[more]
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Project description:BackgroundObesity has reached epidemic proportions in the United States. It is implicated in the development of a variety of chronic disease states and is associated with increased levels of inflammation and oxidative stress. The objective of this study is to examine the effect of Medifast's meal replacement program (MD) on body weight, body composition, and biomarkers of inflammation and oxidative stress among obese individuals following a period of weight loss and weight maintenance compared to a an isocaloric, food-based diet (FB).MethodsThis 40-week randomized, controlled clinical trial included 90 obese adults with a body mass index (BMI) between 30 and 50 kg/m2, randomly assigned to one of two weight loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. The dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan.ResultsWeight loss at 16 weeks was significantly better in the Medifast group (MD) versus the food-based group (FB) (12.3% vs. 6.9%), and while significantly more weight was regained during weight maintenance on MD versus FB, overall greater weight loss was achieved on MD versus FB. Significantly more of the MD participants lost >or= 5% of their initial weight at week 16 (93% vs. 55%) and week 40 (62% vs. 30%). There was no difference in satiety observed between the two groups during the weight loss phase. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators.ConclusionsOur data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements in a number of health-related parameters during weight maintenance, including inflammation and oxidative stress, two key factors more recently shown to underlie our most common chronic diseases.Trial registrationClinicalTrials.gov NCT01011491.
| S-EPMC2851659 | biostudies-literature
Project description:BACKGROUND:Social networks influence obesity patterns, but interventions to leverage social incentives to promote weight loss have not been well evaluated. OBJECTIVE:To test the effectiveness of gamification interventions designed using insights from behavioral economics to enhance social incentives to promote weight loss. DESIGN:The Leveraging Our Social Experiences and Incentives Trial (LOSE IT) was a 36-week randomized, controlled trial with a 24-week intervention and 12-week follow-up. PARTICIPANTS:One hundred and ninety-six obese adults (body mass index ≥ 30) comprising 98 two-person teams. INTERVENTIONS:All participants received a wireless weight scale, used smartphones to track daily step counts, formed two-person teams with a family member or friend, and selected a weight loss goal. Teams were randomly assigned to control or one of two gamification interventions for 36 weeks that used points and levels to enhance collaborative social incentives. One of the gamification arms also had weight and step data shared regularly with each participant's primary care physician (PCP). MAIN OUTCOME MEASURES:The primary outcome was weight loss at 24 weeks. Secondary outcomes included weight loss at 36 weeks. KEY RESULTS:At 24 weeks, participants lost significant weight from baseline in the control arm (mean: - 3.9 lbs; 95% CI: - 6.1 to - 1.7; P < 0.001), the gamification arm (mean: - 6.6 lbs; 95% CI: - 9.4 to - 3.9; P < 0.001), and the gamification arm with PCP data sharing (mean: - 4.8 lbs; 95% CI: - 7.4 to - 2.3; P < 0.001). At 36 weeks, weight loss from baseline remained significant in the control arm (mean: - 3.5 lbs; 95% CI: - 6.1 to - 0.8; P = 0.01), the gamification arm (mean: - 6.3 lbs; 95% CI: - 9.2 to - 3.3; P < 0.001), and the gamification arm with PCP data sharing (mean: - 5.2 lbs; 95% CI: - 8.5 to - 2.0; P < 0.01). However, in the main adjusted model, there were no significant differences in weight loss between each of the intervention arms and control at either 12, 24, or 36 weeks. CONCLUSIONS:Using digital health devices to track behavior with a partner led to significant weight loss through 36 weeks, but the gamification interventions were not effective at promoting weight loss when compared to control. TRIAL REGISTRATION:clinicaltrials.gov Identifier: 02564445.
| S-EPMC6153249 | biostudies-other
Project description:OBJECTIVE:The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity. METHODS:This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI?=?25.0-49.9?kg/m2 to 16 weeks of BWL (n?=?54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n?=?56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models. RESULTS:Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs.?+?0.9 [-0.4 to 2.2], P?<?0.001) and follow-up (-3.2 [-2.0 to -4.5] vs.?+?1.1 [-0.2 to 2.4], P?<?0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P?=?0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P?=?0.378). CONCLUSIONS:Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits.
| S-EPMC5739951 | biostudies-literature
Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).
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Project description:To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.This paper describes the development and evaluation of a text message-based intervention designed to help individuals lose or maintain weight over 4 months.The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (-1.97 kg difference, 95% CI -0.34 to -3.60 kg, P = .02) after adjusting for sex and age. Intervention participants' adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.
| S-EPMC2729073 | biostudies-literature
Project description:A challenge in intensive obesity treatment is making care scalable. Little is known about whether the outcome of physician-directed weight loss treatment can be improved by adding mobile technology.We conducted a 2-arm, 12-month study (October 1, 2007, through September 31, 2010). Seventy adults (body mass index >25 and ?40 [calculated as weight in kilograms divided by height in meters squared]) were randomly assigned either to standard-of-care group treatment alone (standard group) or to the standard and connective mobile technology system (+mobile group). Participants attended biweekly weight loss groups held by the Veterans Affairs outpatient clinic. The +mobile group was provided personal digital assistants to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months. Weight was measured at baseline and at 3-, 6-, 9-, and 12-month follow-up.Sixty-nine adults received intervention (mean age, 57.7 years; 85.5% were men). A longitudinal intent-to-treat analysis indicated that the +mobile group lost a mean of 3.9 kg more (representing 3.1% more weight loss relative to the control group; 95% CI, 2.2-5.5 kg) than the standard group at each postbaseline time point. Compared with the standard group, the +mobile group had significantly greater odds of having lost 5% or more of their baseline weight at each postbaseline time point (odds ratio, 6.5; 95% CI, 2.5-18.6).The addition of a personal digital assistant and telephone coaching can enhance short-term weight loss in combination with an existing system of care. Mobile connective technology holds promise as a scalable mechanism for augmenting the effect of physician-directed weight loss treatment.clinicaltrials.gov Identifier: NCT00371462.
| S-EPMC3684245 | biostudies-literature
Project description:ContextHypothalamic injury often leads to rapid, intractable weight gain causing hypothalamic obesity, which is associated with increased risk of cardiovascular and metabolic morbidity and mortality. There are no approved or effective pharmacological treatments for hypothalamic obesity, and conventional lifestyle management remains ineffective.ObjectiveTo investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks. Patients also received diet/lifestyle counselling. The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.ResultsEighteen patients completed 24 weeks. Consent withdrawal, eligibility, and serious adverse events (SAE) unrelated to treatment resulted in dropouts. One patient experienced a Tesomet-related SAE of exacerbated pre-existing anxiety leading to treatment discontinuation. Tesomet-related adverse events were otherwise mostly mild and included sleep disturbances (Tesomet 50%, placebo 13%), dry mouth (Tesomet 43%, placebo 0%), and headache (Tesomet 36%, placebo 0%). No significant differences in heart rate or blood pressure were observed between groups. Compared to placebo, Tesomet resulted in additional mean (95% CI) weight change of -6.3% ((-11.3; -1.3); P = 0.017), increased the number of patients achieving ≥5% weight loss (Tesomet 8/13, placebo 1/8; P = 0.046), and tended to augment the reduction in waist circumference by 5.7 cm ((-0.1; 11.5); P = 0.054).ConclusionTesomet was welltolerated, did not affect heart rate or blood pressure, and resulted in significant reductions in body weight compared to placebo in adults with hypothalamic obesity.
| S-EPMC9175551 | biostudies-literature
Project description:In the Middle East, the prevalence of overweight/obesity is 80%; however, no studies have yet tested the efficacy of interventions to promote weight loss. The aim of the present study was to test the ability of implementation intentions formed using a volitional help sheet to support weight loss among people who were overweight/obese. Participants (N = 216) enrolling in a weight loss program in Kuwait were randomly allocated either to form implementation intentions using a volitional help sheet (intervention group) or to use the volitional help sheet to think about critical situations and appropriate responses but not form implementation intentions (control group). The main outcome measure was weight at 6-month follow-up. Participants in the intervention condition lost significantly more weight (6.15 kg; -6.58% initial body weight) than those in the control condition (3.66 kg; -4.04% initial body weight), M diff = 2.55% initial body weight, SE diff = .92, t(214) = 2.76, p = .006, 95%CI = .73, 4.36, d = .38. The present study is the first to show that implementation intentions work beyond a Western context and that the volitional help sheet could be used in a variety of cultural contexts to enhance weight-loss programs.
| S-EPMC5636872 | biostudies-other
Project description:Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25-40 kg/m(2)) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (>or=7%), compared with those who lost less than 7%, had significant improvements in steatosis (-1.36 versus -0.41, P < 0.001), lobular inflammation (-0.82 versus -0.24, P = 0.03), ballooning injury (-1.27 versus -0.53, P = 0.03) and NAS (-3.45 versus -1.18, P < 0.001).Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH.
| S-EPMC2799538 | biostudies-literature
Project description:ObjectiveBehavioral weight loss (BWL) programs are not sufficiently effective at promoting high levels of moderate-to-vigorous physical activity (MVPA), despite the clear health benefits of exercise and the possibility that high levels of MVPA may improve long-term weight loss. This three-arm randomized controlled trial tested the hypotheses that 1) BWL interventions with an intensive focus on exercise would result in higher amounts of MVPA and greater long-term weight loss, compared to standard BWL, and 2) among interventions with an intensive focus on exercise, outcomes would be superior when skills for exercise promotion were taught from an acceptance-based theoretical framework (which fosters willingness to accept discomfort in the service of valued behaviors), versus a traditional behavioral approach.MethodThree hundred and twenty adults with overweight/obesity received group-based BWL for induction of weight loss (Months 1-6) and were randomized to receive one of three interventions for weight loss maintenance (Months 7-18): continued standard behavioral treatment (BT), behavioral treatment with an emphasis on exercise (BT + PA), or acceptance-based treatment with an emphasis on exercise (ABT + PA).ResultsMVPA and percent weight loss did not significantly differ by condition at 12 or 18 months. Participants engaging in relatively higher levels of MVPA had greater long-term weight losses compared to participants engaging in lower levels of MVPA.ConclusionsFurther clinical innovations are needed so that participants in BWL programs can more readily adopt and maintain the recommended amounts of MVPA. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
| S-EPMC8341135 | biostudies-literature