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.
Full Title of Study: “Healthy Start to Feeding Pilot Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: May 31, 2020
The purpose of this research study is to pilot test a prevention program to promote healthy introduction of solid foods and healthy weight gain among infants. Introduction of complementary foods (i.e., foods besides formula or breast milk) represents a major dietary milestone for infants. The current study will test the feasibility of a 3-session intervention encouraging healthy introduction of complementary foods and use of a responsive feeding approach. Feasibility of the intervention and the impact of the Healthy Start to Feeding (HSF) intervention on obesity risk factors and growth will be explored. This will be achieved through exploration of the following aims and hypotheses:
Aim 1: Determine feasibility of the intervention and family satisfaction with the treatment.
H1: Families assigned to the intervention condition will attend equal to or greater than 67% of treatment sessions.
H2: Families receiving the intervention will rate the program as helpful and consistent with the families' needs and priorities.
Aim 2: Test the impact of the HSF intervention on growth trajectories, appetite regulation, and diet at post-treatment.
H1: Infants receiving the intervention will experience lower incidence of high weight-for-length (> 85th percentile) compared to infants in the control condition.
H2: Infants in the treatment condition will show greater satiety responsiveness and lower food responsiveness as assessed through a well-validated parent-report measure (Baby Eating Behavior Questionnaire; Llewellyn, van Jaarsveld, Johnson, Carnell, & Wardle, 2010).
H3: Infants in the treatment condition will consume a greater variety of fruits and vegetables than infants in the control condition as assessed through a food frequency questionnaire completed by parents.
- Behavioral: Healthy Start to Feeding
- 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.
Arms, Groups and Cohorts
- Experimental: Healthy Start to Feeding Intervention
- 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.
- No Intervention: Control
- Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention.
Clinical Trial Outcome Measures
- Weight-for-Length Percentile
- Time Frame: Weight and length will be measured at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
- Infant anthropometrics of weight and length will be measured and used to calculate weight-for-length percentile standardized for age and gender.
- Appetite Regulation
- Time Frame: The BEBQ will be completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).
- Infant satiety and food responsiveness will be 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.
- Fruit and Vegetable Variety
- Time Frame: The Block Food Frequency Questionnaire will be 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 will be assessed using the parent-report Block Food Frequency Questionnaire. Scores are calculated for: Calories, Protein, Total fat, Carbohydrate, Calcium, Phosphorus, Iron, Sodium, Potassium, Vitamins (A, B1, B2, B6, C, D, E), Niacin, Saturated fat, Monounsaturated fat, Polyunsaturated fat, Cholesterol, Fiber, Folate, Zinc, Magnesium, Cryptoxanthin, Lutein, Lycopene, Retinol, Pro-Vitamin A carots, Grams solid food, % of kcal from fat, % of kcal from carb, % kcal from sweets, Fiber from beans, Fiber from vegetables and fruits, Fiber from grains, Servings of vegetables, Frequency of eating fruits/fruit juices, Servings of bread/cereal/rice/pasta, Servings of meat/fish/poultry/beans/eggs, Servings of milk/yogurt/cheese, Frequency of eating fats/oils/sweet. The minimum value for all variables 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.
- 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.
- Time Frame: The measure of family satisfaction will be completed at post-treatment (when the child is 9 months of age).
- Caregivers in the treatment condition will complete a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker. Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating higher agreement. Information from each individual item will be used, and no total or subscale scores will be computed. Parents also provide qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.
- Treatment Attendance
- Time Frame: Attendance of sessions at study month 2, study month 4, and study month 7 will be recorded. The average number of the three sessions attended by each family will also be computed (range 0-3 with higher numbers indicating higher attendance).
- Treatment attendance will be tracked for each family.
Participating in This Clinical Trial
- 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
- Known infant developmental delay
- Impaired infant fine or gross motor skills
- Condition currently impacting the infant's feeding and eating
Gender Eligibility: All
Minimum Age: 3 Months
Maximum Age: 10 Months
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Cincinnati
- Children’s Hospital Medical Center, Cincinnati
- Provider of Information About this Clinical Study
- Principal Investigator: Cathy Stough, Assistant Professor – University of Cincinnati
- Overall Official(s)
- Cathleen Stough, PhD, Principal Investigator, University of Cincinnati
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