Lifestyle Changes Through Exercise and Nutrition

Obesity Clinical Trial

— LEAN  

Official title:

The Lifestyle Changes Through Exercise and Nutrition (LEAN) Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863887
• Other study ID #: PBRC 2016-018
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: September 23, 2017

Study information

• Verified date: June 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 23, 2017
• Est. primary completion date: September 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight loss	Percent weight loss will be calculated at 6 and 12 months.	Month 6 and Year 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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