Pediatric ObesityNCT03071419
A Nutrition and Parenting Program for Fathers and Their Pre-school Age Children
A study testing Nutrition and Parenting Intervention in people with Pediatric Obesity, run by University of Connecticut at 2 sites in United States.
Trial summary
This pilot study evaluates the feasibility and impact of a father-focused childhood obesity prevention program on paternal food-related parenting practices, mealtime behaviors and father/child nutrition and physical activity behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Nutrition and Parenting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 30 Apr 2019
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- "Father" eligible for a federal food assistance or related program (e.g. SNAP) or living in an area with >30% poverty
- Having at least one preschool age child (ages 3-5 years old)
- At least 18 years of age and able to speak English
Who cannot join
- No presence or interaction with child during meal or snack times.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hockanum School, Head Start Program
East Hartford, Connecticut, 06118
Manchester Preschool Center
Manchester, Connecticut, 06042
About this study
Official title: Father-Focused Nutrition and Parenting Program to Help Prevent Childhood Obesity in Preschool Age Children
This pilot study evaluates the feasibility and impact of a father-focused childhood obesity prevention program on paternal food-related parenting practices, mealtime behaviors and father/child nutrition and physical activity behaviors. Half of participants (low-income father and child dyads) will receive an intervention immediately while the other half of participants will serve as a wait-list control group and receive the intervention at a later date.
Read the detailed description
All participants (low-income father and child dyads) will receive an 8 session (2 hours/session) (DAD) including community-based, hands-on, nutrition and parent education intervention with between-session technology enhancements. Dyads will be randomly assigned within groups of 10 to DAD or a wait-list control group (DELAY). Assessments will be conducted at pre, post and 1 month post including a subset of data from cohabiting mothers to assess moderating influences on outcomes.
- Conditions
- Pediatric Obesity
- Being tested
- Nutrition and Parenting Intervention
- Keywords
- fathers
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Parenting InterventionBehavioural
The proposed intervention will evaluate and explore the unique influences that low-income fathers have on their preschool age children's obesogenic behaviors and obesity risk.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Parenting Intervention | Experimental | Participants (n=30, father/child dyads in groups of 10) will receive an 8 session (2 hours/session) community-based intervention including nutrition and parent education with between-session technology enhancements. Receives: Behavioral: Nutrition and Parenting Intervention |
| Wait-list Control | Active comparator | Participants (n=30, father/child dyads in groups of 10) will serve as a wait-list control group and receive the same Nutrition and Parenting Intervention after completing pre and post assessments several weeks apart. Receives: Behavioral: Nutrition and Parenting Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Feeding Practices Questionnaire
Food-related parenting practices including parental support, control, structure, feeding
Measured: Change from baseline at 8 weeks
Secondary outcomes (4)
Father & child diet quality
Diet quality assessed using Healthy Eating Index (24 hour recall)
Measured: Change from baseline at 8 weeks
Father & child BMI/BMI Z-Score
Measured: Change from baseline at 8 weeks
Meals in Our Household questionnaire
Mealtime behaviors and practices including shopping, meal planning, cooking, family meals
Measured: Change from baseline at 8 weeks
Healthy Kids Questionnaire
Father and child nutrition behaviors including vegetable and sweetened beverage intake frequency \& Physical activity behaviors including play and screen time
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study startDec 2016
- Primary completion31 Dec 2018
- Study completion30 Apr 2019
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 Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amy Mobley, University of Connecticut
- Investigators
- Amy R Mobley, PhD, RD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071419
- Sponsor's protocol ID
- H15-338
- Other IDs
- 1R21HD087817-01
- Status last verified
- Jun 2019
- First submitted
- 26 Feb 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mobley AR, Gans KM, Adamsons K, Huedo-Medina TB. Feasibility, Acceptability, and Preliminary Outcomes of a Father-Focused Childhood Obesity Prevention Program for Low-Income Families with Preschool-Age Children. Child Obes. 2023 Jan;19(1):13-24. doi: 10.1089/chi.2021.0225. Epub 2022 Mar 11.
PubMed 35275734
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Father-Focused Nutrition and Parenting Program to Help Prevent Childhood Obesity in Preschool Age Children
- ClinicalTrials.gov ID
- NCT03071419
- Acronym / sponsor ID
- H15-338
- Conditions
- Pediatric Obesity
- Keywords
- fathers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 Mar 2017 (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 pilot study evaluates the feasibility and impact of a father-focused childhood obesity prevention program on paternal food-related parenting practices, mealtime behaviors and father/child nutrition and physical activity behaviors. Half of participants (low-income father and child dyads) will receive an intervention immediately while the other half of participants will serve as a wait-list control group and receive the intervention at a later date.
Detailed description
All participants (low-income father and child dyads) will receive an 8 session (2 hours/session) (DAD) including community-based, hands-on, nutrition and parent education intervention with between-session technology enhancements. Dyads will be randomly assigned within groups of 10 to DAD or a wait-list control group (DELAY). Assessments will be conducted at pre, post and 1 month post including a subset of data from cohabiting mothers to assess moderating influences on outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Parenting Intervention | Experimental | Behavioral: Nutrition and Parenting InterventionParticipants (n=30, father/child dyads in groups of 10) will receive an 8 session (2 hours/session) community-based intervention including nutrition and parent education with between-session technology enhancements. |
| Wait-list Control | Active comparator | Behavioral: Nutrition and Parenting InterventionParticipants (n=30, father/child dyads in groups of 10) will serve as a wait-list control group and receive the same Nutrition and Parenting Intervention after completing pre and post assessments several weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- "Father" eligible for a federal food assistance or related program (e.g. SNAP) or living in an area with >30% poverty
- Having at least one preschool age child (ages 3-5 years old)
- At least 18 years of age and able to speak English
Key exclusion criteria (1 listed)
- No presence or interaction with child during meal or snack times.
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 |
|---|---|---|
| Nutrition and Parenting InterventionThe proposed intervention will evaluate and explore the unique influences that low-income fathers have on their preschool age children's obesogenic behaviors and obesity risk. | Behavioural | Nutrition and Parenting Intervention, Wait-list Control |
Primary outcome
Comprehensive Feeding Practices Questionnaire
Time frame: Change from baseline at 8 weeks
Food-related parenting practices including parental support, control, structure, feeding
4 secondary outcomes
Father & child diet quality
Time frame: Change from baseline at 8 weeks
Father & child BMI/BMI Z-Score
Time frame: Change from baseline at 8 weeks
Meals in Our Household questionnaire
Time frame: Change from baseline at 8 weeks
Healthy Kids Questionnaire
Time frame: Change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 35275734Mobley AR, Gans KM, Adamsons K, Huedo-Medina TB. Feasibility, Acceptability, and Preliminary Outcomes of a Father-Focused Childhood Obesity Prevention Program for Low-Income Families with Preschool-Age Children. Child Obes. 2023 Jan;19(1):13-24. doi: 10.1089/chi.2021.0225. Epub 2022 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
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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.
Amy R Mobley, PhD, RD principal investigator
University of Connecticut
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Parenting Intervention in people with Pediatric Obesity, run by University of Connecticut at 2 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comprehensive Feeding Practices Questionnaire (time frame: Change from baseline at 8 weeks). 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 NCT03071419, 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 5 Jun 2019.