Healthy Families Clinic and Teaching Kitchen Program
ClinicalTrials.gov processed this data on October 20, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
ENROLLING BY INVITATION (See Contacts and Locations)Verified October 2023 by Massachusetts General Hospital, American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation
Sponsor
Massachusetts General HospitalInformation Provided by (Responsible Party)
Lauren G. Fiechtner, M.D.Clinicaltrials.gov Identifier
NCT05640414Other Study ID Numbers: 2022P002892
First Submitted: November 23, 2022
First Posted: December 7, 2022
Last Update Posted: October 23, 2023
Last Verified: October 2023
History of Changes
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
---|---|
|
|
Study Design
Study Type | Interventional |
---|---|
Anticipated Enrollment | 125 participants |
Design Allocation | Non-Randomized |
Interventional Model | Single Group Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | Healthy Families Clinic and Teaching Kitchen Program |
Study Start Date | February 1, 2023 |
Anticipated Primary Completion Date | September 30, 2024 |
Anticipated Study Completion Date | September 30, 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
---|---|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Change in BMI at 6 months [0-6 months] Weight in kg and height in meters will be combined to report BMI in kg/m^2, as reported in the electronic health record
- Change in Food Insecurity Status at 3 months [0-3 months] Food insecurity status assessed by the Hunger Vital Signs questionnaire
- Change in Diet Quality at 3 months [0-3 months] Diet quality assessed by an abbreviated food frequency questionnaire
Secondary Outcome Measures
- Change in Binge Eating Symptoms at 3 months [0-3 months] Binge eating symptoms assessed by questionnaire
- Change in Blood Pressure at 6 months [0-6 months] Blood pressure as reported in the electronic health record
- Change in Sleep at 3 months [0-3 months] Sleep duration as reported by questionnaire
- Change in Physical Activity at 3 months [0-3 months] Physical activity as reported by questionnaire
- Change in Screen Time at 3 months [0-3 months] Screen time as reported by questionnaire
Eligibility Criteria
Ages Eligible for Study | (Child, Adult, Older Adult) |
---|---|
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
|
Exclusion Criteria |
|
Contacts and Locations
Sponsors and Collaborators | Massachusetts General Hospital, American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation |
---|---|
American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation | |
Locations |
|
More Information
Additional Relevant MeSH Terms
- Overweight
- Metabolic Syndrome
- Overnutrition
- Nutrition Disorders
- Body Weight
- Insulin Resistance
- Hyperinsulinism
- Glucose Metabolism Disorders
- Metabolic Diseases