The Effects of a Weight Management Program on Body Weight and Quality of Life

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02219763
Collaborator
(none)
50
1
8
6.2

Study Details

Study Description

Brief Summary

Evaluate the impact of a 12-week behavioral weight management program on body weight and quality of life. We hypothesize that participants will lose body weight and see improved quality of life after program completion.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. Findings from this study will also help with program development and improvement within our center. The already established weight management program is called Healthy Habits for Life (HHL) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions).

    All patients who are enrolled in the Healthy Habits for Life group program at the Weight Center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. At this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the IWQOL-lite quality of life questionnaire.

    After completion of the 12 HHL group sessions, all patients at the Weight Center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. At this visit, subjects participating in the research study will again be provided with the IWQOL-lite questionnaire to fill out.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Longitudinal Study to Investigate the Effects of a 14-visit Comprehensive Lifestyle Weight Management Program on Body Weight and Quality of Life
    Study Start Date :
    Jun 1, 2014
    Anticipated Primary Completion Date :
    Feb 1, 2015
    Anticipated Study Completion Date :
    Feb 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Weight Change [Approximately 4 months after enrollment]

      The primary outcomes will be change in body weight comparing body weight at the start of the behavior change program and at the end. This includes weight at the initial individual visit, weights at each of the 12 group visits and body weight at the end of the group program.

    Secondary Outcome Measures

    1. Quality of Life [Approximately 4 months after enrollment]

      Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program.

    Other Outcome Measures

    1. Blood laboratory values [Approximately 4 months after enrollment]

      Labs collected include: Albumin, Alkaline Phosphatase, Total Bilirubin, Total Protein, ALT, AST, HbA1C, Lipids and Insulin. These labs will be collected at a patients first visit to the Weight Center and again after completion of the group program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • English speaking adults aged 18 or older

    • BMI ≥ 25

    • Enrolled in HHL program at the MGH Weight Center

    Exclusion Criteria:
    • Non-English speaking patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MGH Weight Center, Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Sonja S Goedkoop, MSPH, RD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Goedkoop, Sonja, Registered Dietitian, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02219763
    Other Study ID Numbers:
    • 2014P001032
    First Posted:
    Aug 19, 2014
    Last Update Posted:
    Aug 19, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2014