Healthy Lifestyle Program: A Novel Group-based Training
October 6, 2021 updated by: Richard J. Joseph, M.D., Brigham and Women's Hospital
The Healthy Lifestyle Program involves twelve, 2-hour seminars during which participants will learn how to build healthy behaviors through a combination of individual and group exercises.
Participants will use lessons from the seminars to pursue health goals and learn the basics of physical fitness, nutrition, sleep & recovery, stress management, and weight management for optimal health.
Throughout the program, participants will be supported by a behavior coach along with dedicated fitness training, dietary strategy, and stress management support.
As part of this next installment of the program, we are conducting a study of the Healthy Lifestyle Program to capture outcome data, including weight/BMI, blood pressure, hemoglobin A1c, and lipid profile.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preferential access to the HLP is provided folks who live in the neighborhoods of Roxbury, Dorchester, and Mattapan. However, this is certainly not exclusive and we continue to have participants from all around the greater Boston area, especially now that the program is being delivered virtually.
Exclusion Criteria:
- There are no groups of people who are excluded from participating in the program, except for the specified by the age cut offs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist Control Group
|
|
|
Active Comparator: Healthy Lifestyle Program Intervention Arm
|
An intensive behavior change curriculum designed to help create and sustain healthy habits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BMI
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2021
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
November 1, 2022
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
October 19, 2021
Last Update Submitted That Met QC Criteria
October 6, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2021P002707
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.