Trial Outcomes & Findings for Family Based Mindfulness Intervention (NCT NCT01974102)

Results Overview

Attendance rates (average number of sessions) were compared across groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-04-06

Participant Flow

In Phase 1, 20 parent-child dyads started assessments,17 continued post baseline and provided feedback for initial pilot/development phase of PMH+N and C+N interventions. In Phase 2, forty-two parent-preschooler dyads were randomly assigned to receive either the 8-week PMH+N or C+N intervention. Thirty-eight dyads started the intervention

Participant milestones

Participant milestones
Measure	Lifestyle Both active and control groups will receive counseling on nutrition and physical activity. Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.	Prevention Intervention Active group will receive 8 weeks of mindfulness based parenting stress intervention Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling. Mindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention
Overall Study STARTED	22	20
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family Based Mindfulness Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle n=22 Participants Both active and control groups will receive counseling on nutrition and physical activity. Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling.	Prevention Intervention n=20 Participants Active group will receive 8 weeks of mindfulness based parenting stress intervention Lifestyle counseling: Active and control participants will receive nutritional and physical activity counseling. Mindfulness Based Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention.	Total n=42 Participants Total of all reporting groups
Age, Continuous Age	31.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	30.2 years STANDARD_DEVIATION 6.3 • n=7 Participants	31 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race & Ethnicity African American, Hispanic and Other	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race & Ethnicity Caucasian	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Attendance rates (average number of sessions) were compared across groups.

Outcome measures

Outcome measures
Measure	Lifestyle n=15 Participants Session attendance in Control group	Prevention Intervention n=19 Participants Session Attendance in Mindfulness based Intervention group
Attendance	5.7 Sessions Standard Deviation 1.7	7.1 Sessions Standard Deviation 1.2

SECONDARY outcome

Timeframe: 8 weeks

Population: Children were assessed Pre and Post intervention for weight and height to determine BMI percentiles

A comparison between groups to determine the impact of the intervention on BMI percentile.

Outcome measures

Outcome measures
Measure	Lifestyle n=15 Participants Session attendance in Control group	Prevention Intervention n=19 Participants Session Attendance in Mindfulness based Intervention group
Change in BMI Percentile	12 BMI percentile change Standard Deviation 25.5	1.1 BMI percentile change Standard Deviation 16.1

Adverse Events

Lifestyle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prevention Intervention

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

Dr. Rajita Sinha

YALE UNIVERSITY SCHOOL OF MEDICINE

Phone: 2038592840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place