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Overweight and ObesityNCT02456623

Obesity Intervention for Low-Income African American Preschoolers

A study testing Intervention in people with Overweight and Obesity, run by Eastern Michigan University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (> 85th BMI %tile). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Sep 2013to Sep 2017
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parents of children enrolled in Head Start preschool in Detroit, MI will be included. Parents must be 18 years of age or older and their child must be of preschool age, between 3 and 5 years of age. Based on recruitment from Detroit Head Start, families will be low-income and of African American descent. Children will have a current body mass index percentile at or above the 85th percentile.
  • Exclusion Criteria: Child BMI percentile below the 85th percentile.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Michigan University

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Parent Focused Obesity Intervention for Low-Income African American Preschoolers

The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (> 85th BMI %tile). Half of the participants will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. The remaining participants will receive an attention comparison control condition (ACCC), which includes one home visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of parents receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to ACCC.

Read the detailed description

This study will do a preliminarily validation of a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (> 85th BMI %tile). Participants will be randomly assigned to an intervention or attention control condition. Those in the intervention will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. Sessions include psycho-education and skills building exercises. The attention comparison control condition (ACCC) participants will receive one home visit, 7 newsletters and 4 monthly support phone calls. The content of this condition also focuses on nutrition and activity knowledge, motivation and parenting. Outcomes for the intervention and ACC conditions will be assessed at baseline, post-intervention and at a 6-month and 1-year followed up. Child BMI %tile, consumption of fruits/vegetables and sugary beverages, and activity level will be analyzed to examine intervention effectiveness across time.

Being tested
Intervention, Attention Control
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Home-based session targeting the parent

  • Attention ControlBehavioural

    Attention condition with newsletters and support phone calls

Study groups in NCT02456623
Study groupRoleWhat they receive
InterventionExperimentalBehavioral intervention that targets the parent of a preschool age child who is overweight. The intervention is 8 sessions in length. Each session is expected to last 1-1.5 hours and will be carried out in the participant's home over 4 months. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to these factors. Intervention content for the parent will be based on Motivational Interviewing principles.
Receives: Behavioral: Intervention
Attention ControlActive comparatorThe attention control condition includes 1 initial Motivational Interviewing (MI) session conducted in the home. The content of the MI session will be the same as for the intervention participants. Following this session, parents will receive bi-monthly newsletters that will include content similar to what intervention participants receive. AC participants will receive a total of 7 newsletters; 2 on nutrition, 2 on physical activity, 2 on parenting behavior and 1 on community resources. AC participants will also receive a monthly 20-min phone call designed to review newsletter content and answer parent questions.
Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Child Body Mass Index (BMI)

    Change in child BMI will be assessed between baseline and 5-month follow-up.

    Measured: 5-months

  2. Change in child fruit, vegetable, and sugary beverage intake using the Block Food Frequency Questionnaire for children

    Change in child fruit and vegetable intake between baseline and 5-month follow-up will be collected using the Block Food Frequency Questionnaire for children.

    Measured: 5-months

  3. Change in child physical activity level assessed using accelerometers

    Change in child's activity level between baseline and 5-month follow-up will be assessed using accelerometers, which will be worn for four days time at each assessment point.

    Measured: 5-months

Secondary outcomes (3)

  1. Change in parent nutrition/physical activity knowledge, assessed via a self-report survey

    Change in parent knowledge between baseline and 5-month follow-up will be assessed via a self-report survey

    Measured: 5-months

  2. Change in parent motivation for health behavior change, assessed using the "readiness ruler"

    Change in parent's motivation for health behavior change between baseline and 5-month follow-up will be assessed using the "readiness ruler", which is a self-report survey.

    Measured: 5-months

  3. Change in parenting Behavior, assessed using the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale

    Change in parenting behavior between baseline and 5-month follow-up will be assessed using two self-report parent surveys, the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale.

    Measured: 5-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02456623
Sponsor's protocol ID
1R03DK097444-01
Status last verified
Dec 2019
First submitted
8 Jan 2015
Last updated
12 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Overweight and Obesity, run by Eastern Michigan 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 3 inclusion and 0 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 12 Dec 2019. 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?

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?

Change in Child Body Mass Index (BMI) (time frame: 5-months). The study lists 3 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 NCT02456623.

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 12 Dec 2019.

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