Child ObesityNCT03950453
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
A study testing Parenting Mindfully for Health Nutrition (PMH) in people with Child Obesity, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity
- What is being tested?
- Parenting Mindfully for Health Nutrition (PMH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2018to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with a child between 2-5 years
- BMI of parent ≥30kg/m2
- Parents aged 18 yrs or older
- High parent stress (PSS mean score ≥25)
- Low income family as determined by HHS Poverty Guidelines
Who cannot join
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
- Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
- Inadequate English proficiency to complete questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Yale Stress Center: Yale University
New Haven, Connecticut, 06519
About this study
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.
Read the detailed description
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.
- Conditions
- Child Obesity
- Being tested
- Parenting Mindfully for Health Nutrition (PMH), Contact Control Nutrition (C+N), Non-randomized historical control (WLC) assessment only
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Mindfully for Health Nutrition (PMH)Behavioural
PMH will include included the following components:
- mindfulness strategies as outlined in the MBSR manual,
- mindful parenting concepts,
- mindful eating and awareness of family choices;
- self and child monitoring of food intake, PA and emotional reactivity;
- utilizing mindfulness for emotion regulation and distress tolerance,
- behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)
Contact Control Nutrition (C+N)Behavioural
Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.
Non-randomized historical control (WLC) assessment onlyOther
Also called assessment only group
Non-randomized, historical control group with only assessments during intervention and follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parenting Mindfully for Health Nutrition (PMH) |
| Contact Control Nutrition (C+N) | Active comparator | Contact control intervention (C) + nutrition and physical activity counseling (N). Receives: Behavioral: Contact Control Nutrition (C+N) |
| Historical Control (WLC) non-randomized | Other | Non-randomized, historical control group with only assessments during intervention and follow-up period. Receives: Other: Non-randomized historical control (WLC) assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start11 Nov 2018
- Primary completion30 Jun 2023
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cohort study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajita Sinha, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950453
- Sponsor's protocol ID
- 2000023271
- Other IDs
- 1R01DK117651-01A1
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41786283
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
- ClinicalTrials.gov ID
- NCT03950453
- Acronym / sponsor ID
- 2000023271
- Conditions
- Child Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| Parenting Mindfully for Health Nutrition (PMH) | Experimental | Behavioral: Parenting Mindfully for Health Nutrition (PMH)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 | Behavioral: Contact Control Nutrition (C+N)Contact control intervention (C) + nutrition and physical activity counseling (N). |
| Historical Control (WLC) non-randomized | Other | Other: Non-randomized historical control (WLC) assessment onlyNon-randomized, historical control group with only assessments during intervention and follow-up period. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Family with a child between 2-5 years
- BMI of parent ≥30kg/m2
- Parents aged 18 yrs or older
- High parent stress (PSS mean score ≥25)
- Low income family as determined by HHS Poverty Guidelines
Key exclusion criteria (3 listed)
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
- Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
- Inadequate English proficiency to complete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting Mindfully for Health Nutrition (PMH)PMH will include included the following components: 1. mindfulness strategies as outlined in the MBSR manual, 2. mindful parenting concepts, 3. mindful eating and awareness of family choices; 4. self and child monitoring of food intake, PA and emotional reactivity; 5. utilizing mindfulness for emotion regulation and distress tolerance, 6. behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA) | Behavioural | Parenting Mindfully for Health Nutrition (PMH) |
| Contact Control Nutrition (C+N)Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling. | Behavioural | Contact Control Nutrition (C+N) |
| Non-randomized historical control (WLC) assessment onlyAlso: assessment only groupNon-randomized, historical control group with only assessments during intervention and follow-up period. | Other | Historical Control (WLC) non-randomized |
Primary outcome
Parent Stress change from Pre to Post intervention
Time frame: Baseline Pre-intervention to Post intervention at 12 weeks
Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Child BMI change post intervention and at short term 6 month follow-up
Time frame: Change from Pre-intervention to post-intervention (week 12) and at 6 month short term 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.
Child food intake change
Time frame: Baseline Pre-intervention and at post-intervention (week 12)
Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.
Parenting Behavior Change
Time frame: TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)
Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT)
4 secondary outcomes
Parent Stress change from Post intervention to follow up period over 24-months
Time frame: 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
Time frame: Baseline compared to 12-month, 18-month and 24-month timepoint
Child food intake change
Time frame: Baseline Pre-intervention and at post-intervention (week 12)
Parenting Stress Inventory (PSI)
Time frame: PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 41786283Fogelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajita Sinha principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Mindfully for Health Nutrition (PMH) in people with Child Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Stress change from Pre to Post intervention (time frame: Baseline Pre-intervention to Post intervention at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.