AzTrials
AzTrials

ObesityRuralLITENCT00912652

Rural Lifestyle Intervention Treatment Effectiveness Trial

A study testing lifestyle intervention in people with Obesity, run by University of Florida at 8 sites in United States.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Obesity
What is being tested?
lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
8 sitesUnited States
Study dates
Jun 2008to Jun 2014
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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 21 to 75 years
  • Body Mass Index: 30 to 45 kg/m**2

Who cannot join

  • 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.
  • Metabolic exclusions: fasting blood glucose > 125 mg/dl at screening if not known to be diabetic (diabetic patients under active treatment will be enrolled if approved by primary provider); fasting serum triglycerides > 400 mg/dl at screening; resting blood pressure > 140/90 mm Hg.
  • Medication exclusions: antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or Tuberculosis; chemotherapeutic drugs; or use of prescription weight-loss drugs within six months.
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Levy County

    Bronson, Florida, 32621

  • Flagler County

    Bunnell, Florida, 32110

  • Dixie County

    Cross City, Florida, 32628

  • Putnam County

    East Palatka, Florida, 32131

  • Suwannee County

    Live Oak, Florida, 32064

  • Baker County

    Macclenny, Florida, 32063

  • Lafayette County

    Mayo, Florida, 32066

  • Bradford County

    Starke, Florida, 32091

Other trials in United States

About this study

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.

Read the detailed description

Higher rates of obesity, sedentary lifestyle, and coronary heart disease are observed in rural than in non-rural areas of the U.S., yet the treatment of obesity in the rural population has received little attention. Efficacy trials, conducted in academic health centers, show that lifestyle interventions can produce sufficient weight reductions to improve health, but very few trials have been carried out in medically underserved community settings. Moreover, the high intensity of treatments used in efficacy studies represents a barrier to dissemination into rural settings. The existing infrastructure of the United States Department of Agriculture Cooperative Extension Service, with over 2900 offices nationwide, may serve as a valuable resource for bringing lifestyle interventions to rural areas. Preliminary data from our rural obesity research program show promising findings for lifestyle interventions delivered through Extension offices. The next logical step in this line of research is to determine the minimum intensity of treatment required to produce clinically meaningful, long-term weight reductions. We propose to conduct a single-blind, multi-site, randomized controlled trial in obese adults (N=542) to evaluate the effects of LOW, MODERATE, and HIGH doses of lifestyle treatment on two-year changes in body weight, compared to an education CONTROL condition. The LOW intensity condition reflects the dose of group treatment commonly used in community settings, whereas the HIGH dose corresponds to the intensity level employed in efficacy trials. The MODERATE intensity intervention represents a treatment dose that our preliminary data suggest may provide benefits comparable to the HIGH intensity intervention. Our principal hypothesis is that both the MODERATE and HIGH interventions will produce greater weight reductions at two years than either the LOW or CONTROL conditions. We will also evaluate the proportion of participants in each condition, who achieve clinically significant weight losses, and we will examine changes in metabolic risk factors, dietary intake, physical activity, and quality of life. We will calculate the cost-effectiveness of the interventions, and we will investigate potential mediators of long-term change.

Conditions
Obesity
Being tested
lifestyle intervention, Health Education Control
Keywords
obesity, rural health, exercise
Medical subject headings
Obesity, Motor Activity

What participants receive

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

  • lifestyle interventionBehavioural

    Three doses of lifestyle intervention will be compared to an education control condition.

  • Health Education ControlBehavioural

    Health education control group will receive 16 session of health education related to diet and exercise over a two-year period.

Study groups in NCT00912652
Study groupRoleWhat they receive
High Intensity Lifestyle InterventionExperimentalHigh intensity group will receive 48 sessions of lifestyle intervention over a two-year period
Receives: Behavioral: lifestyle intervention
Mod. Intensity Lifestyle InterventionExperimentalModerate intensity group will receive 32 sessions of lifestyle intervention over a two-year period.
Receives: Behavioral: lifestyle intervention
Low Intensity Lifestyle InterventionExperimentalLow intensity group will receive 16 sessions of lifestyle intervention over a two-year period.
Receives: Behavioral: lifestyle intervention
Health Education ControlActive comparatorHealth education control group will receive 16 sessions of health education related to diet and exercise over a two-year period.
Receives: Behavioral: Health Education Control

What is being measured

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

  1. body weight

    Measured: two years

Secondary outcomes (9)

  1. blood pressure

    Measured: two years

  2. lipid profile

    Measured: two years

  3. glycemic control

    Measured: two years

  4. High-sensitivity C-reactive protein (hsCRP)

    Measured: two years

  5. physical activity

    Measured: two-years

  6. physical performance

    Measured: two-years

  7. dietary intake

    Measured: two-years

  8. waist circumference

    Measured: two-years

  9. health-related quality of life

    Measured: two-years

Timeline

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

  1. First posted3 Jun 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2013
  4. Study completionJun 2014

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00912652
Sponsor's protocol ID
RuralLITE-N
Other IDs
R18HL087800
Acronym
RuralLITE
Status last verified
Apr 2018
First submitted
29 May 2009
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25376396

  • Radcliff 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.

    PubMed 31899170

  • Bauman 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.

    PubMed 31245006

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle intervention in people with Obesity, run by University of Florida at 8 sites 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 2 inclusion and 4 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

body weight (time frame: two years). 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 NCT00912652, which also lists 3 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 5 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in