Healthy Start to Feeding Intervention

NCT03597061 | Completed Results

• 1 other identifier: 2017-7248
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will test the impact of a 3-session obesity prevention program targeting healthy introduction of solid foods in infancy on growth trajectories, appetite regulation, and diet. The investigators will also test the feasibility and family satisfaction with the treatment. Healthy infants with normal and elevated weight-for-length will be enrolled in the study at 3 months of age and complete an initial study visit to assess baseline anthropometrics,demographics, parental feeding practices and beliefs, and infant appetite. Infants will than be randomly assigned to either the treatment condition (n = 20) or control condition (n = 20). Infants in the control condition will receive no intervention or further contact with the study team besides for completion of a final study assessment visit when the child is 9 months old. Infants in the treatment condition will receive a 3 session intervention targeting healthy introduction of solid foods, with study visits occurring when the child is 4 months, 6 months, and 9 months old. All families will complete a final study visit to complete post-treatment period measurements, which will include infant anthropometrics and parent-report of infant appetite, infant diet, and parental feeding practices and beliefs. Outcomes include: weight-for-length percentile, infant satiety responsiveness, infant food responsiveness, and infant fruit and vegetable consumption. Family satisfaction and treatment attendance will also be assessed.

Conditions

Weight, Body; Diet Habit

Keywords

obesity prevention; infant; complementary feeding; diet variety; weight-for-length; food responsiveness; satiety responsiveness

Outcome Measures

Primary Outcomes (3)

• Weight-for-Length Percentile

  Infant anthropometrics of weight and length were measured and used to calculate weight-for-length percentile standardized for age and gender.

  Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).

• Appetite Regulation

  Infant satiety and food responsiveness was measured using the parent-report Baby Eating Behavior Questionnaire (BEBQ). The BEBQ provides subscale scores for "Food Responsiveness", "Enjoyment of Food", "Satiety Responsiveness", and "Slowness in Eating" with each subscale score ranging from 1 to 5, with 5 representing higher values on that construct. Each subscale score is computed as the average of all individual items on that subscales.

  The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).

• Fruit and Vegetable Variety

  Fruit and vegetable variety was assessed using the parent-report Block Food Frequency Questionnaire. Scores were calculated for servings of vegetables per day and servings of fruits per day. The minimum value is 0. There is no upper-bound for the maximum value, as this is dependent on the individual participant's food consumption. Higher numbers indicate greater consumption. Only post-treatment results are presented since infants had not been introduced to solid foods at the time of baseline.

  The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).

Secondary Outcomes (2)

• Family Satisfaction - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.

  The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).

• Treatment Attendance

  Attendance of sessions at study month 2 (session 1), study month 4 (session 2), and study month 7 (session 3) was recorded. The number of sessions that each participant attended was calculated.

Study Arms (2)

Healthy Start to Feeding Intervention

EXPERIMENTAL

Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age.

Behavioral: Healthy Start to Feeding

Control

NO INTERVENTION

Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.

Interventions

Healthy Start to Feeding BEHAVIORAL

The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding.

Healthy Start to Feeding Intervention

Eligibility Criteria

• Age: 3 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant aged 2-3 months at study recruitment
• Infant not previously introduced to complementary foods (i.e., any food besides formula or breastmilk)
• Infant born at \> 38 weeks gestation
• Infant weight-for-length \> 10th percentile
• Parent is fluent English speaker

You may not qualify if:

• Known infant developmental delay
• Impaired infant fine or gross motor skills
• Condition currently impacting the infant's feeding and eating

Sponsors & Collaborators

• University of Cincinnati: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• Ojha S, Elfzzani Z, Kwok TC, Dorling J. Education of family members to support weaning to solids and nutrition in later infancy in term-born infants. Cochrane Database Syst Rev. 2020 Jul 25;7(7):CD012241. doi: 10.1002/14651858.CD012241.pub2.

  PMID: 32710657 DERIVED

MeSH Terms

Conditions

Body Weight; Feeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Results Point of Contact

• Title: Cathleen Stough, Ph.D.
• Organization: University of Cincinnati

odarcc@ucmail.uc.edu

513-556-5589

Study Officials

• Cathleen Stough, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Infants will be assigned to either the treatment or control condition.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 24, 2018
• Study Start: November 1, 2018
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: May 10, 2023
• Results First Posted: July 15, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data collected at baseline will be made available at the time of acceptance of the first publication presenting this data, which will be submitted for publication no later than 1 year following the completion of baseline data collection. All other data collected throughout the project will be made available at the time of acceptance of the primary treatment outcomes paper, which will be submitted for publication no later than 1 year following the completion of the last post-treatment visit.
• Access Criteria: Requesting researchers and investigators will be asked to use the data only for IRB-approved or exempted research purposes and to present only aggregate descriptions of data that do not identify any one participant.

Locations

US (1)