Promoting Weight-Loss in African American Cancer Survivors in the Deep South

Not Applicable

Completed

• Conditions: Weight Loss; Cancer
• Interventions: Behavioral: Weight Loss Plus; Behavioral: Control; Behavioral: Weight Loss Only

• Registration Number: NCT03150381
• Lead Sponsor: University of Alabama at Birmingham

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).

Study Timeline

• Study Start: 2012-05-01
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Weight Loss Plus	Weight Loss Plus	Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight) plus community-level strategies to support healthy weight. Strategies are based on CDC's recommended community strategies and are developed by local contractors. They include expanded farmers markets/gardens, improvement to walking trails, etc.
Control	Control	Educational materials and optional participation in community-wide cancer awareness activities.
Weight Loss Only	Weight Loss Only	Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight).

Primary Outcome Measures

Name	Time	Method
Weight	Baseline to 6 months	Measured weight (nearest kg)

Secondary Outcome Measures

Name	Time	Method
Waist Circumference	Baseline to 24 months	Measured circumference (nearest cm)
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 24 months	Measured weight (nearest kg)
Social Support for Diet and Exercise Behaviors	Baseline to 24 months	self report measure of social support (family, friend) in performing diet and exercise behaviors
Self Efficacy for Diet and Exercise Behaviors	Baseline to 24 months	self report measure of confidence in performing diet and exercise behaviors
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	Baseline to 24 months	self report measure of dietary intake

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States