Obesity
Conditions
Keywords
weight loss, behavioral, primary care, lifestyle
Brief summary
The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.
Interventions
BEHAVIORALweight loss intervention - self directed
BEHAVIORALweight loss intervention - peer coach
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-75 years * Body mass index (BMI) 30-50 kg/m2 * Receiving primary care services at one of the practices participating in this study
Exclusion criteria
* Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening) * Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity * Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months) * Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site * Likely to relocate out of the area in the next 2 years * Participation in another randomized research project * Weight loss \> 10 pounds in past six months * History of bariatric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 6, 12, and 18 months | change in body weight (kg) from baseline to follow-up assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment adherence | 6, 12, and 18 months | Treatment adherence will be assessed by the number of treatment sessions and phone calls completed. |
| treatment burden | 6, 12, and 18 months | Behavioral burden of treatment will be assessed with self-report questionnaires including items about the perceived burden of behavioral targets such as self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships. |
| treatment satisfaction | 6, 12, and 18 months | Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved. |
| side effects | 6, 12, and 18 months | Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with treatment. |
| physical activity | 6, 12, and 18 months | Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ). |
| physical and social functioning | 6, 12, and 18 months | Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning. |
| mood | 6, 12, and 18 months | The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered. |
| healthcare utilization | 6, 12, and 18 months | Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected. |
| quality of life | 6, 12, and 18 months | Quality of life will be assessed through the validated Short-Form 12 (SF-12), which provides measures of health-related quality of life for physical and mental health. |
Countries
United States
Outcome results
None listed