Behavior, AdolescentBGW In-PersonNCT06557317
In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
A study testing Black Girls for Wellness In-Person in people with Behavior, Adolescent and Childhood Obesity, run by Cornell University at 1 site in United States.
Trial summary
The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Behavior, Adolescent, Childhood Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Black Girls for Wellness In-Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-18 years of age
- self-identify as Black or African American
- have obesity (>=95th percentile BMI)
- 18 years or older.
- proficiency in speaking English.
- live in the same household as the adolescent who will also be enrolled.
- prepares the majority (>50%) of meals in the household.
Who cannot join
- pregnant or within 3 months postpartum.
- participated in a formal weight management program within 6 months prior to study.
- currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function.
- have previously undergone bariatric surgery.
- have type 2 diabetes.
- unable to speak English or have developmental conditions that interfere with ability to communicate.
- pregnant or within 3 months postpartum.
- unable to speak English or have developmental conditions that interfere with ability to communicate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brownsville Neighborhood Health Action Center
Brooklyn, New York, 11212
Elana Martins, 718-312-6135, emartin8@health.nyc.gov
About this study
Official title: Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus
The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.
Read the detailed description
Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.
The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.
- Conditions
- Behavior, Adolescent, Childhood Obesity, Diabetes Mellitus, Type 2, Pediatric Obesity, Glucose Metabolism Disorders, Metabolic Disease
- Being tested
- Black Girls for Wellness In-Person
- Keywords
- Adolescents, In-Person Lifestyle Program, Diabetes prevention, Black girls, Obesity
- Medical subject headings
- Adolescent Behavior, Pediatric Obesity, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overweight, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Girls for Wellness In-PersonBehavioural
Weekly for 12 weeks, adolescent/caregiver dyads will attend 1) an in-person Wellness Session (mindfulness, nutrition lesson, dance class, program reflection) (90 min/wk) and 2) a home cooking experience using ingredients provided at the Wellness Session (60 min/wk).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Adolescent/Caregiver Dyads | Experimental | Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience. Receives: Behavioral: Black Girls for Wellness In-Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.
Measured: Baseline, 12 weeks [end of study]
Secondary outcomes (10)
Change in dermal carotenoids level
Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Measured: Baseline, 12 weeks [end of study]
Change in percent time sedentary
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Measured: Baseline, 12 weeks [end of study]
Change in percent time spent in light activity
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Measured: Baseline, 12 weeks [end of study]
Change in percent time spent in moderate to vigorous activity
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in moderate and vigorous activity will be calculated.
Measured: Baseline, 12 weeks [end of study]
Change in HbA1c
HbA1c will be assessed through a blood draw.
Measured: Baseline, 12 weeks [end of study]
Change in lipid profile
Total, high-density, low-density cholesterol, and triglycerides will be assessed through a blood draws.
Measured: Baseline, 12 weeks [end of study]
Change in body mass index
Height will be measured using a stadiometer to the nearest decimal point in cm. Weight will be measured using a scale to the nearest decimal in kg. Body mass index will be calculated using kg/m^2.
Measured: Baseline, 12 weeks [end of study]
Change in body fat percentage
Body fat percentage will be measured using a scale to the nearest decimal.
Measured: Baseline, 12 weeks [end of study]
Change in waist circumference
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Measured: Baseline, 12 weeks [end of study]
Change in high blood pressure status
Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.
Measured: Baseline, 12 weeks [end of study]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startAug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tashara M Leak, PhD, RD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557317
- Sponsor's protocol ID
- 0148278
- Acronym
- BGW In-Person
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06557317
- Acronym / sponsor ID
- BGW In-Person / 0148278
- Conditions
- Behavior, Adolescent, Childhood Obesity, Diabetes Mellitus, Type 2, Pediatric Obesity, Glucose Metabolism Disorders, Metabolic Disease
- Keywords
- Adolescents, In-Person Lifestyle Program, Diabetes prevention, Black girls, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.
Detailed description
Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.
The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Adolescent/Caregiver Dyads | Experimental | Behavioral: Black Girls for Wellness In-PersonAdolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 12-18 years of age
- self-identify as Black or African American
- have obesity (>=95th percentile BMI)
- 18 years or older.
- proficiency in speaking English.
Key exclusion criteria (8 listed)
- pregnant or within 3 months postpartum.
- participated in a formal weight management program within 6 months prior to study.
- currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function.
- have previously undergone bariatric surgery.
- have type 2 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black Girls for Wellness In-PersonWeekly for 12 weeks, adolescent/caregiver dyads will attend 1) an in-person Wellness Session (mindfulness, nutrition lesson, dance class, program reflection) (90 min/wk) and 2) a home cooking experience using ingredients provided at the Wellness Session (60 min/wk). | Behavioural | Intervention Adolescent/Caregiver Dyads |
Primary outcome
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
Time frame: Baseline, 12 weeks [end of study]
Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.
10 secondary outcomes
Change in dermal carotenoids level
Time frame: Baseline, 12 weeks [end of study]
Change in percent time sedentary
Time frame: Baseline, 12 weeks [end of study]
Change in percent time spent in light activity
Time frame: Baseline, 12 weeks [end of study]
Change in percent time spent in moderate to vigorous activity
Time frame: Baseline, 12 weeks [end of study]
Change in HbA1c
Time frame: Baseline, 12 weeks [end of study]
Change in lipid profile
Time frame: Baseline, 12 weeks [end of study]
Change in body mass index
Time frame: Baseline, 12 weeks [end of study]
Change in body fat percentage
Time frame: Baseline, 12 weeks [end of study]
Change in waist circumference
Time frame: Baseline, 12 weeks [end of study]
Change in high blood pressure status
Time frame: Baseline, 12 weeks [end of study]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tashara M Leak, PhD, RD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Girls for Wellness In-Person in people with Behavior, Adolescent and Childhood Obesity, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tashara M Leak, PhD, RD (607-255-7664, tml226@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores (time frame: Baseline, 12 weeks [end of study]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.