Cancer, Weight Loss
Conditions
Brief summary
This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.
Detailed description
This is a 3-arm cluster randomized controlled study that compares a trained lay provided weight loss program vs. the same program plus community-based weight management strategies vs. general cancer prevention education on weight loss and other clinical outcomes (primary outcomes) and healthy behaviors, and psychosocial functioning (secondary outcomes).
Interventions
BEHAVIORALWeight Loss Only
24- month weight loss program (year 1: weekly in person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)
BEHAVIORALWeight Loss Plus
Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
BEHAVIORALControl
Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Single Blind (Participant)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* African American breast, colon, or prostate cancer survivor (Index Participant) * Family member (support person) of African American breast, colon, or prostate cancer survivor (Family Member Participant) * Live, work, or attend school in target county * BMI \>= 25 kg/m2
Exclusion criteria
* Pregnant or planning to become pregnant in the next year * Known major medical or psychological condition known to influence body weight * Uncontrolled hypertension (BP \> 160 mmHg systolic or \>100 mmHg diastolic) * medicated or poorly controlled diabetes (glucose \> 126) Cardiovascular event in the preceding 12 months * History of gastric bypass or bariatric surgery * History of psychiatric hospitalization in past 2 years * History of substance abuse or eating disorder * Any other condition by which a medical professional has suggested diet modification, physical activity and/or weight reduction would be contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline to 6 months | Measured weight (nearest kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipids | Baseline to 24 months | Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL) |
| Blood Pressure | Baseline to 24 months | Measured blood pressure (mmHG) - systolic and diastolic |
| Weight | Baseline to 12 months | Measured weight (nearest kg) |
| Waist Circumference | Baseline to 24 months | Measured circumference (nearest cm) |
| Self Efficacy for Diet and Exercise Behaviors | Baseline to 6 months | self report measure of confidence in performing diet and exercise behaviors |
| Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | Baseline to 6 months | self report measure of dietary intake |
| Social Support for Diet and Exercise Behaviors | Baseline to 6 months | self report measure of social support (family, friend) in performing diet and exercise behaviors |
Countries
United States
Outcome results
None listed