Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK117651-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenting Mindfully for Health Nutrition (PMH) | Experimental | Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child. |
|
| Contact Control Nutrition (C+N) | Active Comparator | Contact control intervention (C) + nutrition and physical activity counseling (N). |
|
| Historical Control (WLC) non-randomized | Other | Non-randomized, historical control group with only assessments during intervention and follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenting Mindfully for Health Nutrition (PMH) | Behavioral | PMH will include included the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent Stress change from Pre to Post intervention | Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress. | Baseline Pre-intervention to Post intervention at 12 weeks |
| Child BMI change post intervention and at short term 6 month follow-up | Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores. | Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up |
| Child food intake change | Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake. | Baseline Pre-intervention and at post-intervention (week 12) |
| Parenting Behavior Change | Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT) | TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Stress change from Post intervention to follow up period over 24-months | Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress. | Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints |
| Child BMI change at long term term follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Parent BMI | Parent height will be measured with a stadiometer, and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. | baseline |
| Parent BMI |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rajita Sinha | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Yale Stress Center: Yale University | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41786283 | Derived | Fogelman N, Bernstein H, Bautista T, Savoye M, Chaplin TM, Silverman WK, Jastreboff AM, Sinha R. Mindfulness Intervention for Parent Stress and Childhood Obesity Risk: A Randomized Trial. Pediatrics. 2026 Mar 6:e2025072230. doi: 10.1542/peds.2025-072230. Online ahead of print. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2024 | |
| Reset | Jul 22, 2024 | |
| Release | Apr 30, 2025 | |
| Reset | May 16, 2025 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2022 | Feb 13, 2024 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2024 | Jul 22, 2024 | |||
| Apr 30, 2025 |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
cohort study
Not provided
Not provided
participant and outcomes assessor
|
| Contact Control Nutrition (C+N) | Behavioral | Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling. |
|
| Non-randomized historical control (WLC) assessment only | Other | Non-randomized, historical control group with only assessments during intervention and follow-up period. |
|
|
Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores. |
| Baseline compared to 12-month, 18-month and 24-month timepoint |
| Child food intake change | Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake. | Baseline Pre-intervention and at post-intervention (week 12) |
| Parenting Stress Inventory (PSI) | Parent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress. | PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints |
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. |
| at 12 week timepoint |
| Parent BMI | Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. | at 6 month timepoint |
| Parent BMI | Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. | at 12 month timepoint |
| Parent BMI | Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. | at 18 month timepoint |
| Parent BMI | Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol. | at 24 month timepoint |
| May 16, 2025 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |