Clinical trial NCT02863887: Lifestyle Changes Through Exercise and Nutrition
Official title: The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Weight Loss
African American
Community Based
Mobile technology
Translational science
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent weight loss
timeFrame: Month 6 and Year 1
Secondary outcomes:
measure: Change in Body Fat Percentage
timeFrame: Screening, Month 6 and Year 1
measure: Change in Blood Glucose
timeFrame: Screening, Month 6 and Year 1
measure: Change in Blood Pressure
timeFrame: Screening, Month 6 and Year 1
measure: Change in Food Intake
timeFrame: Screening, Month 6 and Year 1
measure: Change in Physical activity
timeFrame: Screening, Month 6 and Year 1
measure: Change in Quality of Life
timeFrame: Screening, Month 6 and Year 1
measure: Satisfaction Questionnaire
timeFrame: Month 6 and Year 1
measure: Change in Blood Cholesterol
timeFrame: Screening, Month 6 and Year 1
measure: Change in Pulse
timeFrame: Screening, Month 6 and Year 1
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert L Newton, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen T, Irwin ML, Dewan AT, Cartmel B, Harrigan M, Ferrucci LM, Sanft T, Li F, Lu L, Salinas YD. Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention. Breast Cancer Res Treat. 2021 Jun;187(2):487-497. doi: 10.1007/s10549-021-06151-5. Epub 2021 Mar 6.
citation: Newton RL Jr, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.