Child Obesity, Parental and Child Obesity, Parental Stress, Parent and Child Stress
Conditions
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.
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.
Interventions
BEHAVIORALLifestyle counseling
Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
BEHAVIORALParenting 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | 8 weeks | Attendance rates (average number of sessions) were compared across groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI Percentile | 8 weeks | A comparison between groups to determine the impact of the intervention on BMI percentile. |
Countries
United States
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Prevention Intervention | Total | Lifestyle |
|---|---|---|---|
| Age, Continuous Age | 30.2 years STANDARD_DEVIATION 6.3 | 31 years STANDARD_DEVIATION 6.6 | 31.6 years STANDARD_DEVIATION 6.9 |
| Race & Ethnicity African American, Hispanic and Other | 14 Participants | 26 Participants | 12 Participants |
| Race & Ethnicity Caucasian | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Female | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 19 |
| other Total, other adverse events | 0 / 15 | 0 / 19 |
| serious Total, serious adverse events | 0 / 15 | 0 / 19 |
Outcome results
Primary
Attendance
Attendance rates (average number of sessions) were compared across groups.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle | Attendance | 5.7 Sessions | Standard Deviation 1.7 |
| Prevention Intervention | Attendance | 7.1 Sessions | Standard Deviation 1.2 |
p-value: <0.015t-test, 2 sided
Secondary
Change in BMI Percentile
A comparison between groups to determine the impact of the intervention on BMI percentile.
Time frame: 8 weeks
Population: Children were assessed Pre and Post intervention for weight and height to determine BMI percentiles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle | Change in BMI Percentile | 12 BMI percentile change | Standard Deviation 25.5 |
| Prevention Intervention | Change in BMI Percentile | 1.1 BMI percentile change | Standard Deviation 16.1 |
p-value: <0.03t-test, 2 sided