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

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

Study Overview

• Status: Completed
• Conditions: Cancer; Weight Loss
• Intervention / Treatment: Behavioral: Weight Loss Only; Behavioral: Weight Loss Plus; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weight Loss Only; Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight).	Behavioral: Weight 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)
Experimental: 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.	Behavioral: Weight 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.
Active Comparator: Control; Educational materials and optional participation in community-wide cancer awareness activities.	Behavioral: Control; Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured weight (nearest kg)	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	Measured circumference (nearest cm)	Baseline to 24 months
Lipids	Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL)	Baseline to 24 months
Blood Pressure	Measured blood pressure (mmHG) - systolic and diastolic	Baseline to 24 months
Weight	Measured weight (nearest kg)	Baseline to 12 months
Weight	Measured weight (nearest kg)	Baseline to 24 months
Social Support for Diet and Exercise Behaviors	self report measure of social support (family, friend) in performing diet and exercise behaviors	Baseline to 6 months
Social Support for Diet and Exercise Behaviors	self report measure of social support (family, friend) in performing diet and exercise behaviors	Baseline to 12 months
Social Support for Diet and Exercise Behaviors	self report measure of social support (family, friend) in performing diet and exercise behaviors	Baseline to 24 months
Self Efficacy for Diet and Exercise Behaviors	self report measure of confidence in performing diet and exercise behaviors	Baseline to 6 months
Self Efficacy for Diet and Exercise Behaviors	self report measure of confidence in performing diet and exercise behaviors	Baseline to 12 months
Self Efficacy for Diet and Exercise Behaviors	self report measure of confidence in performing diet and exercise behaviors	Baseline to 24 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	self report measure of dietary intake	Baseline to 6 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	self report measure of dietary intake	Baseline to 12 months
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	self report measure of dietary intake	Baseline to 24 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: X120329018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No