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

NCT ID: NCT03150381

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Weight Loss Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single Blind (Participant)

Study Groups

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Weight Loss Only

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

Group Type ACTIVE_COMPARATOR

Weight Loss Only

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Weight Loss Plus

Intervention Type BEHAVIORAL

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.

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.

Interventions

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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)

Intervention Type 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.

Intervention Type BEHAVIORAL

Control

Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Monica L Baskin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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X120329018

Identifier Type: -

Identifier Source: org_study_id

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