A Novel Obesity Prevention Program for High-Risk Infants in Primary Care

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are:

* 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized? * 2\) Will it prevent rapid weight gain during infancy?

Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

born 2500 grams or greater

delivery occurring between 37 and 42 weeks gestation

English speaking

infant receiving care provided at our pediatric primary care setting

Disqualifiers

care in the Neonatal Intensive Care Unit (>7 days)

infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)

infant exposure to illicit drugs in utero [with the exception of tetrahydrocannabinol (THC)]

diminished or impaired caregiver cognitive functioning

Trial design

Design model

Parallel

Treatments tested in this trial

  • THRIVE 2.0

    Behavioral

    Overview of content and strategies: 1) Education on stage of development specific to infant feeding, sleep and infant regulation, attunement to cues; 2) Attunement to cues: reinforcing and modeling accurate discernment \& responsiveness to cues; 3) Infant Soothing and Regulation: Coaching alternative strategies for soothing that feeding for non-hungry, fussy infants; 4) Routines \& Strategies: Promoting developmental activities during wake windows and longer consolidated sleep at night as the infant grows.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Conditional Weight Gain

Conditional Weight Gain scores will be calculated using length and weight of the infants. Length and weight will be measured in triplicate by masked research-reliable trained assessors and with standardized anthropometric procedures and averaged at each time point. Infants will be weighed unclothed, in a dry diaper using a Scale-Tronix 4802D Infant scale that is calibrated every day. Infant length will be measured using a Pediatric Stadiometer by O'Leary (PED LB35-07-X). Conditional weight gain is calculated as standardized residuals from the linear regression of anthropometric data (e.g., weight and length) on birthweight, with age and sex entered as covariates. Scores closer to 0 are ideal, with scores higher than 0 indicating more rapid weight gain and scores below 1 indicating slower weight gain. Primary outcomes will include conditional weight gain scores at the 9-month post-treatment time point.

Time frame
At infant age 9-months (post-treatment)

Secondary outcomes

1

Conditional Weight Gain

Conditional Weight Gain scores will be calculated using length and weight of the infants. Length and weight will be measured in triplicate by masked research-reliable trained assessors and with standardized anthropometric procedures and averaged at each time point. Infants will be weighed unclothed, in a dry diaper using a Scale-Tronix 4802D Infant scale that is calibrated every day. Infant length will be measured using a Pediatric Stadiometer by O'Leary (PED LB35-07-X). Conditional weight gain is calculated as standardized residuals from the linear regression of anthropometric data (e.g., weight and length) on birthweight, with age and sex entered as covariates. Scores closer to 0 are ideal, with scores higher than 0 indicating more rapid weight gain and scores below 1 indicating slower weight gain.

Time frame
At infant age 12 months (follow-up)
2

The Baby Eating Behavior Questionnaire

Used to measure infant appetite and contains 5 subscales that assess enjoyment of food, food responsiveness, slowness in eating, and satiety responsiveness, and general appetite. Subscales of the BEBQ have good reliability and the measured appetite traits track throughout infancy and toddlerhood and are related to greater weight gain. Items are scored on a Likert scale ranging from 1 to 5 with higher average scores on each scale indicating more enjoyment of food, food responsiveness, slowness in eating, and satiety responsiveness, respectively.

Time frame
At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
3

The Infant Feeding Style Questionnaire

An 83-item measure of parent feeding beliefs, behaviors, and style with the following subscales: laissez-faire, restrictive, pressuring, responsive and indulgent. Internal reliability measures for the subscales ranged from 0.75 to 0.95. Several sub-constructs, responsive to satiety cues, pressuring with cereal, indulgent pampering and indulgent soothing, were inversely related to infant weight-for-length z-score, meaning higher scores indicate greater risk for obesity.

Time frame
At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
4

The Food Frequency Questionnaire

A validated parent-report measure that assesses infant dietary intake within the previous 7 days. The FFQ measures duration of breast-feeding status, timing of introduction of solid foods, consumption of fruits and vegetables, consumption of proteins, consumption of energy-dense-nutrient-poor foods, and consumption of sugar sweetened beverages. The FFQ correlates well with weighted diaries in infancy. It measures intake across a diverse range of liquid and solid food groups. As infants are gradually introduced to solid foods and become less reliant on milk, the completion time of the measure may increase (requires 5-10 mins to complete).

Time frame
At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator