Clinical trial NCT03150381: Promoting Weight-Loss in African American Cancer Survivors in the Deep South
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 369
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: Baseline to 24 months
measure: Lipids
timeFrame: Baseline to 24 months
measure: Blood Pressure
timeFrame: Baseline to 24 months
measure: Weight
timeFrame: Baseline to 12 months
measure: Weight
timeFrame: Baseline to 24 months
measure: Social Support for Diet and Exercise Behaviors
timeFrame: Baseline to 6 months
measure: Social Support for Diet and Exercise Behaviors
timeFrame: Baseline to 12 months
measure: Social Support for Diet and Exercise Behaviors
timeFrame: Baseline to 24 months
measure: Self Efficacy for Diet and Exercise Behaviors
timeFrame: Baseline to 6 months
measure: Self Efficacy for Diet and Exercise Behaviors
timeFrame: Baseline to 12 months
measure: Self Efficacy for Diet and Exercise Behaviors
timeFrame: Baseline to 24 months
measure: Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
timeFrame: Baseline to 6 months
measure: Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
timeFrame: Baseline to 12 months
measure: Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: