Clinical trial NCT02514889: Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Official title: Is MyPlate.Gov Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-08-04
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 76% of whom are expected to be Latino, 13% African American and 11% 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.

Detailed 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 as effective in helping patients to sustain 1-year weight loss as the DPP approach, more clinicians can be expected to actively engage their obese patients in weight loss efforts.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient-centered Outcome Measure = Self-reported Hunger
timeFrame: 12 months follow-up
measure: Medical Outcome Measure = Body Weight
timeFrame: 12 months follow-up
measure: Meal Satisfaction Yesterday
timeFrame: 12 months follow-up
measure: Feeling Full After Last Meal Yesterday
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 months follow-up
measure: Body Mass Index
timeFrame: 12 months follow-up
measure: Waist Circumference
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: The Children's Clinic of Long Beach (TCC)
state: California
city: Los Angeles
country: United States
facility: UCLA Center for Cancer Prevention & Control Research
state: California
Study officials:
affiliation: UCLA Fielding School of Public Health
name: William J McCarthy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelberg L, Rico MW, Herman DR, Belin TR, Chandler M, Ramirez E, Love S, McCarthy WJ. Comparative effectiveness trial comparing MyPlate to calorie counting for mostly low-income Latino primary care patients of a federally qualified community health center: study design, baseline characteristics. BMC Public Health. 2019 Jul 24;19(1):990. doi: 10.1186/s12889-019-7294-z.