NCT02219763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 19, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

August 15, 2014

Last Update Submit

August 15, 2014

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality of Life

    Approximately 4 months after enrollment

Other Outcomes (1)

  • Blood laboratory values

    Approximately 4 months after enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (over age 18) with a BMI ≥ 25 enrolled in the 12-week Healthy Habits for Life (HHL) group program from the MGH Weight Center will be recruited. Subjects will be recruited over a 5-month period.

You may qualify if:

  • English speaking adults aged 18 or older
  • BMI ≥ 25
  • Enrolled in HHL program at the MGH Weight Center

You may not qualify if:

  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Weight Center, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sonja S Goedkoop, MSPH, RD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja S Goedkoop, MSPH, RD

CONTACT

617-726-6126sgoedkoop@partners.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Dietitian

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 19, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 19, 2014

Record last verified: 2014-06

Locations

US(1)