Lifestyle Changes Through Exercise and Nutrition (LEAN)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Behavioral: Weight loss intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight loss intervention; 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.	Behavioral: Weight loss intervention; The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
Experimental: Delayed Treatment Control Group; 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.	Behavioral: Weight loss intervention; The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent weight loss	Percent weight loss will be calculated at 6 and 12 months.	Month 6 and Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Fat Percentage	The participant's body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240).	Screening, Month 6 and Year 1
Change in Blood Glucose	The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible glucose testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.	Screening, Month 6 and Year 1
Change in Blood Pressure	Blood pressure will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to blood pressure measurement to ensure accurate at rest reading.	Screening, Month 6 and Year 1
Change in Food Intake	The National Cancer Institute (NCI) fat screener estimates the percentage of energy from fat by asking patients to report the frequency of consuming specific foods over the past 12 months. A standard 7-item fruit and vegetable screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and vegetables were consumed in the past month.	Screening, Month 6 and Year 1
Change in Physical activity	The International Physical Activity Questionnaire (IPAQ) questionnaire is a self-report measure of physical activity. The metabolic equivalent task (MET) minutes in each domain of leisure time activity, that is, sedentary, light, moderate, and vigorous intensity, will be calculated. The IPAQ has been shown to be a reliable and valid measure of physical activity and has been sensitive to changes in physical activity resulting from intervention programs.	Screening, Month 6 and Year 1
Change in Quality of Life	. Each participant's quality of life will be assessed using the Impact of Weight on Quality of Life Survey.	Screening, Month 6 and Year 1
Satisfaction Questionnaire	Each participant's satisfaction with the different elements of the study, including the community health coaches, the intervention, and the text messages, will be measured using a questionnaire developed by the investigators.	Month 6 and Year 1
Change in Blood Cholesterol	The Alere Cholestech LDX® Analyzer is engineered to provide accurate, actionable, and readily accessible cholesterol testing results. The Cholestech uses fingerstick sampling and small sample size (40μL) that makes results less time consuming and easy to obtain.	Screening, Month 6 and Year 1
Change in Pulse	Pulse will be measured using an automatic blood pressure cuff (Omeron, Model BP710 or similar). Participants will rest for approximately 5 minutes prior to pulse measurement to ensure accurate at rest reading.	Screening, Month 6 and Year 1

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Robert L Newton, Jr., PhD, Pennington Biomedical Research Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): September 23, 2017
• Study Completion (Actual): September 23, 2017

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Weight Loss; African American; Mobile technology; Community Based; Translational science
• Other Study ID Numbers: PBRC 2016-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO