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

Cancer Clinical Trial

— DSNCARES  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150381
• Other study ID #: X120329018
• Status: Completed
• Phase: N/A
• Start date: May 1, 2012
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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