Lifestyle Changes Through Exercise and Nutrition



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:6/7/2018
Start Date:June 2016
End Date:September 23, 2017

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The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project

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.

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.

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
We found this trial at
1
site
6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
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