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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AT007708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle | Active Comparator | 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. |
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| therapy | Experimental | Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle counseling | Behavioral | Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Attendance rates (average number of sessions) were compared across groups. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI Percentile | A comparison between groups to determine the impact of the intervention on BMI percentile. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajita Sinha, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Stress Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30241766 | Result | Jastreboff AM, Chaplin TM, Finnie S, Savoye M, Stults-Kolehmainen M, Silverman WK, Sinha R. Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention: A Randomized Pilot Study. J Pediatr. 2018 Nov;202:136-142.e1. doi: 10.1016/j.jpeds.2018.07.011. Epub 2018 Sep 18. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Prevention Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years via self report |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attendance | Attendance rates (average number of sessions) were compared across groups. | Posted | Mean | Standard Deviation | Sessions | 8 weeks |
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8 weeks
Not different than clinicaltrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajita Sinha | YALE UNIVERSITY SCHOOL OF MEDICINE | 2038592840 | rajita.sinha@yale.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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| Parenting Mindfully for Health (PMH) | Behavioral | Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race & Ethnicity | Count of Participants | Participants |
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|
|
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| Secondary | Change in BMI Percentile | A comparison between groups to determine the impact of the intervention on BMI percentile. | Children were assessed Pre and Post intervention for weight and height to determine BMI percentiles | Posted | Mean | Standard Deviation | BMI percentile change | 8 weeks |
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|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Prevention Intervention | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |