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

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ClinicalTrials.gov Identifier: NCT02514889
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
William J. McCarthy, Ph.D., University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Calorie-counting Behavioral: MyPlate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is MyPlate.Gov Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Calorie-counting
Intervention protocol adapted from Diabetes Prevention Program lifestyle change intervention.
Behavioral: 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.

Other Name: DPP intensive lifestyle change intervention

Experimental: MyPlate
Intervention protocol adapted from Dietary Approaches to Stop Hypertension dietary pattern.
Behavioral: 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.

Other Name: DASH diet intervention




Primary Outcome Measures :
  1. Patient-centered Outcome Measure = Self-reported Hunger [ Time Frame: 12 months follow-up ]
    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."

  2. Medical Outcome Measure = Body Weight [ Time Frame: 12 months follow-up ]
    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.

  3. Meal Satisfaction Yesterday [ Time Frame: 12 months follow-up ]
    "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.

  4. Feeling Full After Last Meal Yesterday [ Time Frame: 12 months follow-up ]
    "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.


Secondary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 12 months follow-up ]
    Systolic blood pressure assessed on participant's left arm while participant is seated, after at least 5 minutes of rest. Automated, regularly calibrated sphygmomanometer was used with oversize cuffs for obese arms.

  2. Body Mass Index [ Time Frame: 12 months follow-up ]
    Body mass index is weight in kilograms divided by the square of the participant's height measured in meters. Wall-mounted stadiometer was used to assess height. Weekly-calibrated, portable, digital scales were used to assess body weight.

  3. Waist Circumference [ Time Frame: 12 months follow-up ]
    The waist circumference was assessed using research standard waist circumference measuring tapes. The result was measured to closest 0.1 cm. The assessor was instructed to position the measuring tape horizontally around the waist, just above the iliac crest.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514889


Locations
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United States, California
The Children's Clinic of Long Beach (TCC)
Long Beach, California, United States, 90806
UCLA Center for Cancer Prevention & Control Research
Los Angeles, California, United States, 90095-6900
Sponsors and Collaborators
University of California, Los Angeles
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: William J McCarthy, Ph.D. UCLA Fielding School of Public Health
  Study Documents (Full-Text)

Documents provided by William J. McCarthy, Ph.D., University of California, Los Angeles:
Informed Consent Form  [PDF] July 31, 2017


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Responsible Party: William J. McCarthy, Ph.D., Adjunct Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02514889     History of Changes
Other Study ID Numbers: PCORI-1306-01150
First Posted: August 4, 2015    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Fielding School of Public Health Open Data Portal is a web application being built that will enable the sharing of public health research, data and data tools. The platform operates in a secure, HIPPA compliant, cloud environment. The project's de-identified data, protocol and codebook will remain stored in an encrypted form. The portal was expressly designed to make new public health data available through a creative commons framework, available to any researcher willing to comply with UCLA IRB stipulations.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: By 6/30/2018.
Access Criteria: UCLA IRB approval required.

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms