Trial Outcomes & Findings for Diabetes Prevention Program in Youth (NCT NCT03042936)

NCT ID: NCT03042936

Last Updated: 2023-11-22

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

16 weeks

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin Superheroes Club Curriculum A supplement to the Centers for Disease Control and Prevention's adult Diabetes Prevention Program (DPP) designed for youth from culturally diverse, minority backgrounds. The ISC is a 12-month, multilevel program that includes 16 weekly (phase 1), 3 biweekly (phase 2), and 6 monthly (phase 3) sessions. Participants attended sessions that included 60 min of physical fitness and 30 min of education. The education portion included interactive teaching of health-related topics (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using hands-on learning activities (e.g., cooking, crafts, games, and role-play). All physical fitness activities incorporated moderate-intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance).
Overall Study STARTED	33
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Prevention Program in Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Superheroes Club Curriculum n=33 Participants A supplement to the Centers for Disease Control and Prevention's adult Diabetes Prevention Program (DPP) designed for youth from culturally diverse, minority backgrounds. The ISC is a 12-month, multilevel program that includes 16 weekly (phase 1), 3 biweekly (phase 2), and 6 monthly (phase 3) sessions. Participants attended sessions that included 60 min of physical fitness and 30 min of education. The education portion included interactive teaching of health-related topics (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using hands-on learning activities (e.g., cooking, crafts, games, and role-play). All physical fitness activities incorporated moderate-intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance).
Age, Categorical <=18 years	33 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 2 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Insulin Superheroes Club Curriculum n=33 Participants A supplement to the Centers for Disease Control and Prevention's adult Diabetes Prevention Program (DPP) designed for youth from culturally diverse, minority backgrounds. The ISC is a 12-month, multilevel program that includes 16 weekly (phase 1), 3 biweekly (phase 2), and 6 monthly (phase 3) sessions. Participants attended sessions that included 60 min of physical fitness and 30 min of education. The education portion included interactive teaching of health-related topics (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using hands-on learning activities (e.g., cooking, crafts, games, and role-play). All physical fitness activities incorporated moderate-intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance).
Change From Baseline Hemoglobin A1c	-0.5 A1c percentage points Interval -0.6 to -0.2

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks, 6 months, 9 months, 12 months

Population: 0 participants analyzed because data could not be collected.

Outcome measures

Outcome data not reported

Adverse Events

Insulin Superheroes Club Curriculum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joan Han

UTHSC

Phone: 9012876408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place