Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered?
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2017 |
| Start Date: | July 1, 2015 |
| End Date: | July 31, 2017 |
Is MyPlate.Gov Approach to Helping Overweight Patients Lose Weight More Patient-centered?
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.
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.
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.
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.
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)
We found this trial at
2
sites
Los Angeles, California 90095
Principal Investigator: William J McCarthy, Ph.D.
Phone: 310-825-4487
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Long Beach, California 90806
Principal Investigator: Maria Chandler, MD
Phone: 562-933-0432
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