Rural Lifestyle Intervention Treatment Effectiveness Trial
RuralLITE
2 other identifiers
interventional
612
1 country
8
Brief Summary
More and more Americans are becoming overweight. The rates of overweight are especially high in rural areas of the country. Until now, there has been little access to weight management programs in rural areas. This study will examine ways to help individuals from rural counties to manage weight and improve fitness. To do this, three doses of lifestyle treatment (Low, Moderate and High)will be compared to an education control condition. Our principal hypothesis is that both the Moderate and High conditions will have greater weight loss at two years than either the Low or Control conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 2008
Longer than P75 for not_applicable obesity
8 active sites
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, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 5, 2018
April 1, 2018
4.8 years
May 29, 2009
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body weight
two years
Secondary Outcomes (9)
blood pressure
two years
lipid profile
two years
glycemic control
two years
High-sensitivity C-reactive protein (hsCRP)
two years
physical activity
two-years
- +4 more secondary outcomes
Study Arms (4)
High Intensity Lifestyle Intervention
EXPERIMENTALHigh intensity group will receive 48 sessions of lifestyle intervention over a two-year period
Mod. Intensity Lifestyle Intervention
EXPERIMENTALModerate intensity group will receive 32 sessions of lifestyle intervention over a two-year period.
Low Intensity Lifestyle Intervention
EXPERIMENTALLow intensity group will receive 16 sessions of lifestyle intervention over a two-year period.
Health Education Control
ACTIVE COMPARATORHealth education control group will receive 16 sessions of health education related to diet and exercise over a two-year period.
Interventions
Three doses of lifestyle intervention will be compared to an education control condition.
Health education control group will receive 16 session of health education related to diet and exercise over a two-year period.
Eligibility Criteria
You may qualify if:
- Age: 21 to 75 years
- Body Mass Index: 30 to 45 kg/m\*\*2
You may not qualify if:
- Underlying disease likely to limit lifespan and/or increase risk of interventions:cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV, self-reported tuberculosis or treatment); myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; irritable bowel syndrome; previous bariatric surgery; history of organ transplantation; history of musculoskeletal conditions that limit walking; chronic lung diseases that limit physical activity; and any other condition likely to limit five-year life expectancy.
- Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling to travel to Extension office for intervention sessions; participation in another randomized research project; weight loss \> 10 pounds in past six months; likely to move out of the county in next two years; major psychiatric disorder; excessive alcohol intake; BMI \> 45; prior participation in the TOURS trial; and other conditions which in the opinion of staff would adversely affect participation in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Levy County
Bronson, Florida, 32621, United States
Flagler County
Bunnell, Florida, 32110, United States
Dixie County
Cross City, Florida, 32628, United States
Putnam County
East Palatka, Florida, 32131, United States
Suwannee County
Live Oak, Florida, 32064, United States
Baker County
Macclenny, Florida, 32063, United States
Lafayette County
Mayo, Florida, 32066, United States
Bradford County
Starke, Florida, 32091, United States
Related Publications (3)
Perri MG, Limacher MC, von Castel-Roberts K, Daniels MJ, Durning PE, Janicke DM, Bobroff LB, Radcliff TA, Milsom VA, Kim C, Martin AD. Comparative effectiveness of three doses of weight-loss counseling: two-year findings from the rural LITE trial. Obesity (Silver Spring). 2014 Nov;22(11):2293-300. doi: 10.1002/oby.20832.
PMID: 25376396BACKGROUNDRadcliff TA, Cote MJ, Whittington MD, Daniels MJ, Bobroff LB, Janicke DM, Perri MG. Cost-Effectiveness of Three Doses of a Behavioral Intervention to Prevent or Delay Type 2 Diabetes in Rural Areas. J Acad Nutr Diet. 2020 Jul;120(7):1163-1171. doi: 10.1016/j.jand.2019.10.025. Epub 2019 Dec 30.
PMID: 31899170DERIVEDBauman V, Ariel-Donges AH, Gordon EL, Daniels MJ, Xu D, Ross KM, Limacher MC, Perri MG. Effect of dose of behavioral weight loss treatment on glycemic control in adults with prediabetes. BMJ Open Diabetes Res Care. 2019 May 28;7(1):e000653. doi: 10.1136/bmjdrc-2019-000653. eCollection 2019.
PMID: 31245006DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael G. Perri, Ph.D.
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 3, 2009
Study Start
June 1, 2008
Primary Completion
April 1, 2013
Study Completion
June 1, 2014
Last Updated
April 5, 2018
Record last verified: 2018-04