Trial Outcomes & Findings for Family Routines - Healthy Families (NCT NCT03255902)

Last Updated: 2019-07-26

Results Overview

Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

After 6 weeks of classes

Results posted on

2019-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Families Attending Parenting Classes Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family Routines - Healthy Families

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Families Attending Parenting Classes n=7 Participants Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 6 weeks of classes

Population: 2 participants did not complete study

Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

Outcome measures

Outcome measures
Measure	Families Attending Parenting Classes n=5 Participants Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum
Effect of Intervention on Evening Glucose Control.	2 Participants

SECONDARY outcome

Timeframe: Pre intervention to 3 months post intervention

Population: 2 participants did not complete study

3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.

Outcome measures

Outcome measures
Measure	Families Attending Parenting Classes n=5 Participants Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires Parenting classes: Parenting Classes:The Incredible Years curriculum
Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value	-0.3 percent of HbA1c Interval -1.1 to 0.6

Adverse Events

Families Attending Parenting Class

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

Donna Marvicsin, Nurse Practitioner, Pediatric Endocrinology

William Beaumont Hospitals

Phone: 248-568-6932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place