Lifestyle Changes Through Exercise and Nutrition (LEAN)

Pennington Biomedical Research Center

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Behavioral: Weight loss intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02863887

PBRC 2016-018

Details and patient eligibility

About

The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.

Full description

The LEAN Project is a community-based weight loss program that is delivered through churches serving lower-income, obese, African American adults. The intervention will involve training community health coaches to deliver the intervention. These community health coaches will be individuals who are members of the church and who are willing to be trained on how to deliver behaviorally-based, empirically proven, lifestyle change interventions. These community health coaches will be trained by the staff at Pennington Biomedical, who have experience training and delivering these types of interventions. The community health coaches will deliver the intervention through their respective church after being trained. Weekly text messages will be sent to participants in order to supplement the intervention sessions and provide support. The primary aim is to determine if the trained community health coach church-based intervention will result in significant weight loss. Secondary aims will assess blood glucose, cholesterol, physical activity, food intake, and weight related quality of life.

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• self-identify as African American
• a member of a participating church
• age 18-75 years old
• BMI > 30
• own a mobile phone with text message capabilities
• at risk for diabetes (diagnosed nuclear family member or gestational diabetes) or diagnosed with type 2 diabetes
• willing to provide written informed consent
• willing to change diet, physical activity and weight
• able to participate in face-face counselling sessions as scheduled
• low to moderate cardiovascular disease risk

Exclusion criteria

• currently participating in a weight loss program
• currently using weight loss medication or have lost weight (>10 lbs in last year)
• planning to move from the area within the next year
• given birth within the past year, are currently pregnant or plan to become pregnant within the next year
• planning to have bariatric surgery within 2 years
• history of major depression, suicidal behavior or eating disorder
• hospitalization for a mental disorder or substance abuse in the last year
• have cancer or had cancer within the past 5 years.
• serious heart problems such as arrhythmias, cardiomyopathy, congestive heart failure
• stroke or heart attack in the last six months
• high blood pressure [systolic ≥160, or diastolic ≥100]
• chronic inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease
• diseases that are life threatening or that can interfere with or be aggravated by exercise or weight loss
• unwilling or unable to provide informed consent
• physician's or principal investigator's decision to exclude

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Weight loss intervention

Experimental group

Description:

Churches randomized to the intervention condition will receive the community health coach delivered church based intervention for 6 months followed by 6 months of weight maintenance.

Treatment:

Behavioral: Weight loss intervention

Delayed Treatment Control Group

Experimental group

Description:

Churches in the delayed treatment control condition will receive information on various health topics relevant to African Americans, such as strokes, lupus, sickle cell, etc. via text message during the first six months. Participants in this group will not receive any behavioral strategies designed to alter weight, physical activity, or diet during this time. They will receive the community health coach delivered church based weight loss intervention after 6 months.

Treatment:

Behavioral: Weight loss intervention