Overview

This trial is active, not recruiting.

Condition obesity
Treatments calorie-counting, myplate
Phase phase 3
Sponsor University of California, Los Angeles
Collaborator Patient-Centered Outcomes Research Institute
Start date July 2015
End date January 2017
Trial size 261 participants
Trial identifier NCT02514889, PCORI-1306-01150

Summary

Investigators from the University of California-Los Angeles (UCLA) and The Children's Clinic of Long Beach (TCC) are conducting a randomized, controlled comparative effectiveness trial of two government-sanctioned behavior change approaches to weight control with TCC's obese patients. The first approach is the calorie-counting calorie restriction (CC) approach used in the Diabetes Prevention Program. The second approach is the high-satiation/high-satiety approach represented by MyPlate.gov. The MyPlate nutritional goal is to double patient fruit and vegetable intake, legume intake, and whole grain intake. Both conditions stipulate 150 minutes of moderate physical activity a week. Study participants will be 300 of TCC's obese patients, 75% of whom are expected to be Latino, 15% African American and 10% Other Ethnicities.

The interventions will be implemented by trained community lifestyle change coaches with brief support from clinicians. The interventions will include two home visits, two group education sessions and seven telephone behavior change coaching sessions.

Compared to the CC approach, the MyPlate approach is hypothesized to yield better 12 months patient-centered outcomes, particularly self-reported satiety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.
calorie-counting DPP intensive lifestyle change intervention
The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week. Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls.
(Experimental)
Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.
myplate DASH diet intervention
The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week. Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls.

Primary Outcomes

Measure
Patient-centered outcome measure = Self-reported satiety (Visual analogue scales)
time frame: 12 months follow-up
Medical outcome measure = Change in body weight from baseline
time frame: 12 months follow-up

Secondary Outcomes

Measure
Systolic blood pressure
time frame: 12 months follow-up
Body mass index
time frame: 12 months follow-up
Waist circumference
time frame: 12 months follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must be overweight (BMI > 25) or obese adult patient at The Childrens Clinic of Long Beach (TCC), - interested in achieving desirable weight loss through behavior change. - speak English or Spanish. Exclusion Criteria: - Smoking in last 6 months, - Currently pregnant, - Medical condition preventing voluntary change in food choices or level of daily physical activity, - Planning on moving out of the Long Beach area in the next two years. - MyocardiaI Infarction, stroke or atherosclerotic cardiovascular disease procedure within the last 6 months - Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g. End Stage Renal Disease on dialysis, cancer diagnosis or treatment within 2 yrs) - Prior or planned bariatric surgery - Use of prescription weight loss medication (including off label drugs e.g. topiramate, bupropion, byetta) or over-the-counter orlistat within 6 months - Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine) - Unintentional weight loss within past 6 months (≥ 5% of body weight) - Intentional weight loss within past 6 months (≥ 5% of body weight) - Pregnant or nursing within past 6 months - Plans to become pregnant within 18 months - Another member of household is a study participant or trial staff member - Problem alcohol use: Self reported average consumption of > 14 alcoholic drink per week or 5+ drinks on any occasion in past week? for males and >7 drinks per week or 4+ drinks on any occasion in the past week for females - Psychiatric hospitalization in last year - Unstable angina - Blood pressure >160/100 (note: individuals may be rescreened)

Additional Information

Official title Is MyPlate.Gov Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Principal investigator William J McCarthy, Ph.D.
Description The traditional government advice for weight loss in obese patients has been calorie-counting(CC) / portion control. In 2011 the government began recommending the MyPlate approach (MyP) for optimal nutrition and better weight control. The CC condition asks obese patients to reduce their daily calorie intake to less than a recommended calorie target. The MyP approach also limits daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables, and ¼ of daily food choices whole grains. The relative patient-centered outcome effectiveness of the MyP approach versus the CC approach has yet to be tested in clinic patients. Specific Aims: In partnership with a local community clinic, the investigators are conducting a randomized controlled trial (RCT) comparing the patient-centeredness and efficacy of usual care compared to two government-supported lifestyle change approaches to reducing patient obesity risk. Study participants are 300 obese, low income, mostly Latino and African American adult patients or staff associated with a community health center in Long Beach, California. The interventions will be implemented by trained community lifestyle change coaches with brief support from clinicians. The first weight loss approach is the calorie-counting (CC), portion-cutting approach recommended at www.nutrition.gov . The second is the fill-up-sooner-on-fewer-calories approach found at http://www.choosemyplate.gov (MyP). The CC condition asks overweight patients to reduce their daily calorie intake to less than a recommended calorie target. The MyP approach also limits daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables, and ¼ of daily food choices whole grains. MyP uses progressive goal-setting to facilitate a doubling of usual fruit and vegetable intake. To facilitate adherence, the MyP approach also includes home environment changes to make healthier choices easier choices. All conditions encourage doing at least 150 minutes of moderate to vigorous physical activity a week. Primary patient-centered outcomes include self-reported satiety, health-related quality of life, self-efficacy to eat more fruits and vegetables, patient autonomy, and patient satisfaction, all of which are hypothesized to favor the MyP condition at 12 months follow-up relative to the CC condition. The primary medical outcome is a reduction in body weight. Specific Aims Aim #1. Use qualitative information from patients and clinical staff to revise intervention materials and procedures. Aim #2. Use results of a pilot test of the intervention conditions to revise intervention materials and procedures. Aim #3. Conduct a 1-year RCT involving two home visits, two group education classes, and seven telephone support/ lifestyle change coaching calls. Aim #4. Obtain qualitative data from providers and coaches; combine with participant data to assess intervention feasibility, acceptability and perceived usefulness. Aim #5. Disseminate results and recommendations to community groups and public health professionals. Primary patient-centered hypothesis: Compared to the CC approach, the MyP approach will yield better 1-year outcomes on self-reported satiety and systolic blood pressure. Both government-recommended conditions will yield significant and similar 12 months declines in body weight. The MyPlate distillation of the 2010 Dietary Guidelines for Americans shifted the emphasis of nutrition recommendations for desirable weight loss from counting calories to maximizing satiation, through the practical steps of eating MORE fruits and vegetables, MORE whole grains, MORE nonfat dairy, MORE water (and LESS sugary beverages). Calorie counting helps lose excess weight in the short term but rarely is able to sustain desirable weight loss long-term. The MyPlate approach may be easier to sustain because it allows eating up to 25 percent more grams of food even as it reduces baseline calorie intake by 10 percent; the extra daily grams of food help the patient to feel full even while she is losing weight. Because MyPlate is a distillation of recommendations for all healthy Americans, regardless of body size, it can guide eating choices for everyone in the family and do so for a lifetime. If the MyPlate approach is shown to be more effective in helping patients to sustain long-term weight loss, more clinicians can be expected to actively engage their obese patients in weight loss efforts.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.