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

The University of Alabama at Birmingham

Status: Completed

Conditions: Weight Loss; Cancer

Treatments: Behavioral: Weight Loss Plus; Behavioral: Control; Behavioral: Weight Loss Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03150381

X120329018

Details and patient eligibility

About

This study tests evidence-based strategies for weight loss among overweight and obesity cancer survivors and family members in rural Alabama.

Full 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).

Enrollment: 369 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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369 participants in 3 patient groups

Weight Loss Only

Active Comparator group

Description:

Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (\~5-10% of baseline weight).

Treatment:

Behavioral: Weight Loss Only

Weight Loss Plus

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Loss Plus

Control

Active Comparator group

Description:

Educational materials and optional participation in community-wide cancer awareness activities.

Treatment:

Behavioral: Control