Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered?

NCT02514889 | Completed Results

• 1 other identifier: PCORI-1306-01150
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• Patient-centered Outcome Measure = Self-reported Hunger

  Response to question: "Thinking about yesterday, how hungry did you feel during the day?" Response was a mark on a 100mm scale or oral response on a scale from 0 to 100 (for participants assessed via phone), 0="Not at all hungry" and 100="Extremely hungry."

  12 months follow-up

• Medical Outcome Measure = Body Weight

  Body weight, measured in kilograms, was obtained by having shoeless participants dressed in light clothing stand on a regularly calibrated medical scale. Measures were taken twice. If these measures differed by more than 0.2 kg, a third measure was taken and averaged with the other two.

  12 months follow-up

• Meal Satisfaction Yesterday

  "Take a moment to think about the last meal you ate yesterday. Thinking about the last meal you ate, how satisfied were you after the meal?" Response was a mark on a 100 mm visual analogue scale or response to oral question on a scale from 0 to 100 (for participants assessed via phone), with the low end (0) anchored by "Very satisfied" and the high end (100) anchored by "Very unsatisfied." For analysis purposes this measure was reverse-scored, so that higher values represented greater meal satisfaction.

  12 months follow-up

• Feeling Full After Last Meal Yesterday

  "Take a moment to think about the last meal yesterday. Thinking about the last meal you ate, how full did you feel after that meal?" Response was a mark on a 100 mm visual analogue scale (VAS), or oral response to question on a scale from 0 to 100 (for participants assessed via phone), 0="Extremely full" and 100="Not at all full." For analysis purposes this measure was reverse-scored, so that higher values represented greater fullness.

  12 months follow-up

Secondary Outcomes (3)

• Systolic Blood Pressure

  12 months follow-up

• Body Mass Index

  12 months follow-up

• Waist Circumference

  12 months follow-up

Study Arms (2)

Calorie-counting

ACTIVE COMPARATOR

Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.

Behavioral: Calorie-counting

MyPlate

EXPERIMENTAL

Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.

Behavioral: MyPlate

Interventions

Calorie-counting BEHAVIORAL

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.

Also known as: DPP intensive lifestyle change intervention

Calorie-counting

MyPlate BEHAVIORAL

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.

Also known as: DASH diet intervention

MyPlate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

The Children's Clinic of Long Beach (TCC)

Long Beach, California, 90806, United States

Location

UCLA Center for Cancer Prevention & Control Research

Los Angeles, California, 90095-6900, United States

Location

Related Publications (1)

• 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.

  PMID: 31340800 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The original recruitment goal was N=300 but was reduced to N=261 because accrual took longer than expected. Statistical power was nonetheless expected to remain satisfactory for testing the main hypotheses.

Results Point of Contact

• Title: William J. McCarthy, Ph.D., Professor
• Organization: UCLA Fielding School of Public Health, 650 Charles Young Drive, Los Angeles, CA 90095

wmccarth@ucla.edu

310-794-7587

Study Officials

• William J McCarthy, Ph.D.

  UCLA Fielding School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: April 18, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2015
• Primary Completion: March 23, 2017
• Study Completion: July 31, 2017
• Last Updated: November 20, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: By 6/30/2018.
• Access Criteria: UCLA IRB approval required.

Locations

US (2)