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

Primary Purpose

Weight Loss, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Only
Weight Loss Plus
Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Weight Loss Only

Weight Loss Plus

Control

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Weight
Measured weight (nearest kg)

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2017
Last Updated
May 14, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03150381
Brief Title
Promoting Weight-Loss in African American Cancer Survivors in the Deep South
Acronym
DSNCARES
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Single Blind (Participant)
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss Only
Arm Type
Active Comparator
Arm Description
Group-based behavioral weight loss intervention designed to reach clinically significant weight loss (~5-10% of baseline weight).
Arm Title
Weight Loss Plus
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Educational materials and optional participation in community-wide cancer awareness activities.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Only
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Plus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.
Primary Outcome Measure Information:
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Waist Circumference
Description
Measured circumference (nearest cm)
Time Frame
Baseline to 24 months
Title
Lipids
Description
Measured total cholesterol, triglycerides, HDL, LDL, ratio (mg/dL)
Time Frame
Baseline to 24 months
Title
Blood Pressure
Description
Measured blood pressure (mmHG) - systolic and diastolic
Time Frame
Baseline to 24 months
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
Baseline to 12 months
Title
Weight
Description
Measured weight (nearest kg)
Time Frame
Baseline to 24 months
Title
Social Support for Diet and Exercise Behaviors
Description
self report measure of social support (family, friend) in performing diet and exercise behaviors
Time Frame
Baseline to 6 months
Title
Social Support for Diet and Exercise Behaviors
Description
self report measure of social support (family, friend) in performing diet and exercise behaviors
Time Frame
Baseline to 12 months
Title
Social Support for Diet and Exercise Behaviors
Description
self report measure of social support (family, friend) in performing diet and exercise behaviors
Time Frame
Baseline to 24 months
Title
Self Efficacy for Diet and Exercise Behaviors
Description
self report measure of confidence in performing diet and exercise behaviors
Time Frame
Baseline to 6 months
Title
Self Efficacy for Diet and Exercise Behaviors
Description
self report measure of confidence in performing diet and exercise behaviors
Time Frame
Baseline to 12 months
Title
Self Efficacy for Diet and Exercise Behaviors
Description
self report measure of confidence in performing diet and exercise behaviors
Time Frame
Baseline to 24 months
Title
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Description
self report measure of dietary intake
Time Frame
Baseline to 6 months
Title
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Description
self report measure of dietary intake
Time Frame
Baseline to 12 months
Title
Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Description
self report measure of dietary intake
Time Frame
Baseline to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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