NCT02863887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2017

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

July 7, 2016

Last Update Submit

June 4, 2018

Conditions

ObesityDiabetes

Keywords

Weight LossAfrican AmericanCommunity BasedMobile technologyTranslational science

Outcome Measures

Primary Outcomes (1)

  • Percent weight loss

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

    Month 6 and Year 1

Secondary Outcomes (9)

  • Change in Body Fat Percentage

    Screening, Month 6 and Year 1

  • Change in Blood Glucose

    Screening, Month 6 and Year 1

  • Change in Blood Pressure

    Screening, Month 6 and Year 1

  • Change in Food Intake

    Screening, Month 6 and Year 1

  • Change in Physical activity

    Screening, Month 6 and Year 1

  • +4 more secondary outcomes

Study Arms (2)

Weight loss intervention

EXPERIMENTAL

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

Delayed Treatment Control Group

EXPERIMENTAL

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

Interventions

Weight loss interventionBEHAVIORAL

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.

Delayed Treatment Control GroupWeight loss intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • 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.

    PMID: 33677781DERIVED

  • 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.

    PMID: 30143478DERIVED

MeSH Terms

Conditions

ObesityDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Robert L Newton, Jr., PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 11, 2016

Study Start

June 1, 2016

Primary Completion

September 23, 2017

Study Completion

September 23, 2017

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)