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Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose

NCT01542671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-04-04

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study. It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort. The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective. The cost of intervention will be evaluated as it relates to study replication.

Conditions

  • Overweight and Obesity

Interventions

BEHAVIORAL

Intervention

* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24. * Monthly Motivational phone calls with Lifestyle Counselor for the first year * 4 informational DVDs over the two year period * Feedback on submitted food and exercise journals

BEHAVIORAL

Control

* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * 5 informational NIDDK mailings over the two year period

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Memorial Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Charles B Eaton, MD · Memorial Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542671 on ClinicalTrials.gov