Journey to Better Health

NCT02938312 | Completed

• 2 other identifiers: F1007080031U54CA153719
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight

  Measured weight (nearest kg)

  baseline to 6-months

Secondary Outcomes (17)

• Waist Circumference

  baseline to 6-months

• Blood Pressure

  baseline to 6-months

• Lipids

  baseline to 6-months

• Weight

  baseline to 12-months

• Weight

  baseline to 24-months

Study Arms (2)

Weight Loss Only

ACTIVE COMPARATOR

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)

Behavioral: Weight Loss Only

Weight Loss Plus

EXPERIMENTAL

Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity

Behavioral: Weight Loss Plus

Interventions

Weight Loss Only 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.

Weight Loss Only

Weight Loss Plus BEHAVIORAL

Participants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.

Weight Loss Plus

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American female
• Live or work in target county
• BMI \>= 25 kg/m2

You may not qualify if:

• 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)
• Cardiovascular event in the preceding 12 months
• History of gastric bypass 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: August 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 24, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)