Lifestyle Changes Through Exercise and Nutrition

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Behavioral: Weight loss intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss intervention<br>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<br>* 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.<br>|
| Experimental: Delayed Treatment Control Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, African American, Community Based, Mobile technology, Translational science