Adaptation of the Diabetes Prevention Program for Primary Care

This study will be a randomized trial of a weight control intervention, with participants
recruited primarily from primary care practices at the University of Colorado. Study
treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary
research clinic which is part of the University of Colorado School of Medicine. If needed,
administrative study visits, such as for informed consent and for completion of
questionnaires, may take place at offices in the Division of General Internal Medicine. Up
to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of
high-intensity weight loss counseling. During the first 6 months, each participant will be
seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10,
12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out
prior to 6 months. After the first 6 months, the remaining participants will be randomly
assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During
months 7 to 18, individuals in the Standard Maintenance condition will receive informational
handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified
Maintenance condition will continue to have monthly in-person visits with the weight loss
counselor ("Weight Coach").

All participants will use portion-controlled foods to replace 2 meals per day during the
first 6 months of treatment and to replace 1 meal per day during months 7 to 18.
Participants will purchase their own portion-controlled foods, although in-kind
contributions from private industry will be sought to offset participants' food costs. The
study consent form will explicitly describe estimated food costs for study participants. The
cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals
per day) is not expected to increase food costs. Many participants should observe a decrease
in food costs while following the meal plan.

Inclusion Criteria:

- Age 18 to 79

- Able to give informed consent

- Able to keep a food record for 7 days prior to study entry and to complete 2
screening visits and a blood draw prior to enrollment

- Willing to attend all counseling sessions, to complete study-related assessments, and
to be randomized to a treatment condition after 6 months of treatment

- Has a regular primary care physician (if referred from outside the University of
Colorado system)

- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2

- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the
following:

- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including
type 2 diabetes); individuals taking medications for diabetes qualify automatically

- Elevated blood pressure (≥ 130/85), including hypertension (≥ 140/90); individuals
taking anti-hypertensive medication qualify automatically

- Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG
≥ 150); low HDL cholesterol (< 40 for men, < 50 for women); or taking lipid-lowering
medications

- Obstructive sleep apnea -

Exclusion Criteria:

- Medical conditions in which significant weight loss is normally contraindicated (e.g.
pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes,
Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe
internal organ disease); exceptions may be made if a referring physician documents
that it is safe and appropriate for the individual to lose weight

- Treated for cancer within the past 5 years, except for basal cell or squamous cell
skin cancer; exceptions may be made with written permission from a physician

- Myocardial infarction or stroke within the past 6 months

- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled

- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when
controlled

- Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not
been weight stable may be re-screened

- Chronic use of corticosteroids or second-generation antipsychotic medications
(exceptions may be made for individuals using these medications who have been weight
stable for 6 months)

- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g.,
poorly controlled schizophrenia, active substance abuse)

- Untreated major depression (PHQ-9 score ≥ 20)

- Pregnant or trying to become pregnant

- Social situation precluding participation in a research study (e.g., need to care for
a small child or an elderly parent)

- Prior or planned bariatric surgery

- Participation in an organized weight loss program (e.g., Weight Watchers) at the time
of enrollment