Lifestyle Changes Through Exercise and Nutrition

Completed · Not applicable

Conditions studied: Obesity, Diabetes

In brief

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.

Key facts

Study ID

NCT02863887

Run by

Pennington Biomedical Research Center

People needed

97

Starts

2016-06-01

Expected to finish

2017-09-23

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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