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
Behavioral: Healthy Lifestyle Program
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

Brigham and Women's Hospital

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.

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