Trial Outcomes & Findings for Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered? (NCT NCT02514889)

Last Updated: 2017-11-20

Results Overview

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."

Recruitment status

COMPLETED

Study phase

Target enrollment

261 participants

Primary outcome timeframe

12 months follow-up

Results posted on

2017-11-20

Participant Flow

All adult patients in waiting room of two clinics were approached for assessment of eligibility to enroll in the trial. The eligibility assessment period began 4/1/2015 and ended on 2/5/2016. 2,086 patients were approached; screening was completed for 1,889. Of these 1,889, 1,628 were found to be ineligible, leaving 261 to be randomized.

All participants who were enrolled were randomized.

Participant milestones

Participant milestones
Measure	MyPlate Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern. MyPlate: 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.	Calorie-counting Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention. Calorie-counting: 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.
Randomization/Allocation to Condition STARTED	131	130
Randomization/Allocation to Condition COMPLETED	111	106
Randomization/Allocation to Condition NOT COMPLETED	20	24
Intervention Participation STARTED	111	106
Intervention Participation COMPLETED	102	98
Intervention Participation NOT COMPLETED	9	8
Follow-up Assessment Participation STARTED	102	98
Follow-up Assessment Participation COMPLETED	92	86
Follow-up Assessment Participation NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

At beginning of study one female patient refused to have her waist circumference taken by the only research assistant available at the time, who was male, which resulted in loss of data. We subsequently permitted the taking of waist circumference measures over clothing depending on patient preference.