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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02219763
• Other study ID #: 2014P001032
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: August 15, 2014
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: Massachusetts General Hospital
• Contact: Sonja S Goedkoop, MSPH, RD
• Phone: 617-726-6126
• Email: sgoedkoop[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Locations

Country	Name	City	State
United States	MGH Weight Center, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood laboratory values	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.	Approximately 4 months after enrollment	No
Primary	Weight Change	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.	Approximately 4 months after enrollment	No
Secondary	Quality of Life	Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program.	Approximately 4 months after enrollment	No