Family Based Mindfulness Intervention

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01974102
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.

Condition or Disease	Intervention/Treatment	Phase
Parental Stress; Parent and Child Stress; Parental and Child Obesity; Child Obesity	Behavioral: Lifestyle counseling; Behavioral: Parenting Mindfully for Health (PMH)	N/A

Detailed Description

This project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (PMH) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. Parents and toddlers also participated in a Toy Wait Task, a behavioral assay of parenting.The empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (Control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether PMH improved toddler weight, physical activity and parent emotion regulation and healthy eating.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lifestyle Attentional control group will receive weekly meeting to view relaxing video and facilitate discussion along with counseling on nutrition and physical activity for 8 weeks.	Behavioral: Lifestyle counseling; Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
Experimental: therapy Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.	Behavioral: Lifestyle counseling; Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.; Behavioral: Parenting Mindfully for Health (PMH); Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Attendance [8 weeks]

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

Secondary Outcome Measures

1. Change in BMI Percentile [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Between ages 18-70 years;

2. Able to read and write (parent)

3. Family with a child between 2-5 years old

4. BMI of parent in obese category

5. High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index)

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation

2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child

3. Inability to give informed consent

4. Current serious medical disorder precluding participation in physical activity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Stress Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Rajita Sinha, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01974102
• Other Study ID Numbers: 1306012264; 5R21AT007708
• First Posted: Nov 1, 2013
• Last Update Posted: Apr 6, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Obesity; Pediatric Obesity

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Lifestyle	Prevention Intervention
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	22	20
COMPLETED	15	19
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Lifestyle	Prevention Intervention	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	22	20	42
Age (years) [Mean (Standard Deviation) ]
Age	31.6 (6.9)	30.2 (6.3)	31 (6.6)
Sex: Female, Male (Count of Participants)
Female	22 100%	20 100%	42 100%
Male	0 0%	0 0%	0 0%
Race & Ethnicity (Count of Participants)
African American, Hispanic and Other	12 54.5%	14 70%	26 61.9%
Caucasian	10 45.5%	6 30%	16 38.1%

Outcome Measures

1. Primary Outcome

Title	Attendance
Description	Attendance rates (average number of sessions) were compared across groups.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle	Prevention Intervention
Arm/Group Description	Session attendance in Control group	Session Attendance in Mindfulness based Intervention group
Measure Participants	15	19
Mean (Standard Deviation) [Sessions]	5.7 (1.7)	7.1 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle, Prevention Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.015
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in BMI Percentile
Description	A comparison between groups to determine the impact of the intervention on BMI percentile.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lifestyle	Prevention Intervention
Arm/Group Description	Change in Child BMI Percentile from Post- to Pre- treatment in Control group	Change in Child BMI Percentile from Post- to Pre- treatment in Mindfulness based Intervention group
Measure Participants	15	19
Mean (Standard Deviation) [BMI percentile change]	12 (25.5)	1.1 (16.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle, Prevention Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.03
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	Not different than clinicaltrials.gov definitions
Arm/Group Title	Lifestyle		Prevention Intervention
Arm/Group Description	This group will receive attendance control weekly with attendance in a group to watch a relaxing video and generate discussion. Lifestyle counseling: Weekly nutritional and physical activity counseling.		Active group will receive 8 weeks of parenting mindfully for health (PMH) plus nutrition and physical activity (N) counseling Lifestyle counseling: weekly Nutritional and physical activity counseling. Mindfulness Based Parenting Intervention: Active participants will receive 8 weeks of Mindfulness Based Parenting Stress Intervention.
All Cause Mortality
	Lifestyle		Prevention Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/19 (0%)
Serious Adverse Events
	Lifestyle		Prevention Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Lifestyle		Prevention Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/19 (0%)

Limitations/Caveats

Limitations of this study include the small sample size, limited data on the mothers due to participants' time restraints and preference, and short intervention duration.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.