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