AzTrials
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ObesityLEANNCT02863887

Lifestyle Changes Through Exercise and Nutrition

A study testing Weight loss intervention in people with Obesity and Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Diabetes
What is being tested?
Weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteUnited States
Study dates
Jun 2016to 23 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity, Diabetes
Being tested
Weight loss intervention
Keywords
Weight Loss, African American, Community Based, Mobile technology, Translational science
Medical subject headings
Obesity, Diabetes Mellitus, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight loss interventionBehavioural

    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.

Study groups in NCT02863887
Study groupRoleWhat they receive
Weight loss interventionExperimentalChurches 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.
Receives: Behavioral: Weight loss intervention
Delayed Treatment Control GroupExperimentalChurches 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.
Receives: Behavioral: Weight loss intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent weight loss

    Percent weight loss will be calculated at 6 and 12 months.

    Measured: Month 6 and Year 1

Secondary outcomes (9)

  1. Change in Body Fat Percentage

    The participant's body fat percentage is measured using the portable Tanita Body Composition Analyzer (SC-240).

    Measured: Screening, Month 6 and Year 1

  2. 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.

    Measured: Screening, Month 6 and Year 1

  3. 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.

    Measured: Screening, Month 6 and Year 1

  4. 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.

    Measured: Screening, Month 6 and Year 1

  5. 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.

    Measured: Screening, Month 6 and Year 1

  6. Change in Quality of Life

    . Each participant's quality of life will be assessed using the Impact of Weight on Quality of Life Survey.

    Measured: Screening, Month 6 and Year 1

  7. 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.

    Measured: Month 6 and Year 1

  8. 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.

    Measured: Screening, Month 6 and Year 1

  9. 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.

    Measured: Screening, Month 6 and Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion23 Sep 2017
  4. Study completion23 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02863887
Sponsor's protocol ID
PBRC 2016-018
Acronym
LEAN
Status last verified
Jun 2018
First submitted
7 Jul 2016
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 33677781

  • 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.

    PubMed 30143478

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss intervention in people with Obesity and Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent weight loss (time frame: Month 6 and Year 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02863887, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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