Table 1 Completed and other ongoing randomized, controlled trials aiming to prevent obesity through during infancy
From: The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study
Name/trial registry number | Framework | Sample size | Intervention(s) | Outcome(s) |
|---|---|---|---|---|
Completed trials | ||||
Educational intervention to modify bottle-feeding behaviors [73] | Experiential Learning Cycle for Adult Learning | 40 | - Group intervention for Women, Infants, and Children (WIC) participating mothers of 1–2 month old formula-fed infants | - No difference in daily formula intake at 4–5 months |
- Increase awareness of satiety cues | - Intervention group had greater weight gain than control between time of intervention and follow-up at infant age 4–5 months | |||
- Limit bottle size to 6 ounces or less in first 4 months | ||||
First steps for mommy and Me [74] | Motivational Interviewing | 84 | - Primary care provider “negotiations” at well child care to endorse behavior change | - Later introduction of solids |
- Health educator calls between visits to discuss maternal healthy lifestyle plus infant obesity preventive guidance | - Modestly less TV viewing | |||
- Printed Materials | - Larger increases in nocturnal sleep duration from baseline to follow-up and improvements in sleep hygeine | |||
- Monthly group parent training sessions | - No significant difference in weight-for-length z-score | |||
SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Study [71] | Responsive Parenting | 160 | - 2×2 design using home nurse visits among mothers intending to breastfeed | - “Soothe/Sleep” breastfeeding infants slept more, had fewer noctural and total daytime feeds |
- “Soothe/Sleep” - discriminate hunger vs. other distress, educate on soothing strategies, day/night differences | - “Introduction of Solids” infants – later intro & were more likely to accept novel healthy foods at age 1 year | |||
- “Introduction of Solids” - delay introduction, hunger/satiety cues education (2–3 weeks), repeated exposure to vegetables (~4-6 months) | - Infants receiving both interventions had a significantly lower weight-for-length z-score at age 1 year | |||
Health Beliefs | 667 | - Intensive home nurse visitation over first 2 years plus phone support vs. usual care among socially high-risk families | - At age 2 years, BMI significantly lower for intervention group vs. control | |
- Key messages: “Breast is best”, “No solids for me until 6 months”, “I eat a variety of fruit and vegetables every day”, “Only water in my cup”, “I am part of an active family” | - Intervention group ate more vegetables, less meals with TV, and more physical activity | |||
Cognitive Behavioral with Anticipatory Guidance | 698 | - Two modules of group parent education and peer support sessions held co-led by dietician and psychologist timed around a) introduction of solids and b) emergence of autonomy and independence | - Lower BMI-for-age Z-score and less rapid infant weight gain since birth at 13–14 months | |
- Parents instructed to overcome neophobia and increase healthy food acceptance through teaching on healthy infant growth and requirements, variability of intake within/between infants, amount/timing of snacks, hunger/satiety cues | - No difference with control group for BMI at age 2 years | |||
- Parents instructed to help develop infant self-regulation and healthy diet with lessons on managing food refusal/neophobia/fussing, developmental need for autonomy and limit testing, modeling healthy food choices | - Mothers used more responsive feeding practices | |||
- Mothers less likely to use food as a reward or turn meals into a game | ||||
Anticipatory Guidance | 292 | - Primary care anticipatory guidance-based study comparing 3 interventions delivered at well child care by primary care providers plus handouts: Mother focused (maternal eating habits and modeling eating) vs. Infant focused (serving size, introduction of solids, feeding style) vs. usual care | - No difference in growth parameters between groups at 1 year | |
- Mothers in mother and infant focused groups gave less juice and gave more fruit and vegetables than those in the usual care group. | ||||
The Infant Feeding Activity and Nutrition Trial (INFANT) [82–84] | Parent support theory; Social cognitive theory | 542 | - Community-based existing maternal-child health nurse-led groups with dietician led intervention (6 – two hour sessions delivered quarterly) vs. control (usual care) | - At age 20 months there was no difference in BMI between groups, but intervention group showed a modest reduction in sweet snack intake and a modest reduction in TV viewing |
- Developmentally appropriate guidance on parent feeding style, timing of introduction of solids, nutrition, parent modeling, managing food rejection | - No group differences in fruit/veggie/water/sweetened beverage intake, physical activity | |||
Trials with Published Methods | Primary Outcome | |||
Mi Voglio Bene [85] | Anticipatory Guidance | 3610 | - Primary care based delivery of 10 preventive actions (promotion of breastfeeding, delayed introduction of solids, control of protein intake in first 2 years, avoidance of sweetened beverages, avoidance of bottle use after 2 years, promoting physical activity, identification of early adiposity rebound, limit TV viewing, encouraging play, controlling portion size | - BMI at age 6 years |
Prevention of Overweight in Infancy (POI.nz) [86] | Anticipatory Guidance | 800 | - 4 arm trial comparing usual care with usual care plus either a Food, Activity, and Breastfeeding intervention or a Sleep intervention or both interventions delivered in well care supplemented by research nurses, lactation consultants and/or sleep specialists | - BMI at age 2 years |
Healthy Babies [87] | Theory of Planned Behavior | 372 | - Paraprofessional home visits providing guidance on normative growth and development and skill-building on maternal feeding and feeding responsiveness, | - Weight-for-length at age 1 year |
Preventing Childhood Obesity through Early Feeding and Parenting Guidance [88] | Personalized Anticipatory Guidance | 140 | - Community health worker home visits with focus on preventing obesogenic feeding behaviors, parental recognition of cues, play without screen time, and good sleep hygiene | - Weight-for-length at ages 1 and 2 years |
Greenlight Study [89] | Social Cognitive Theory | 865 | - Low literacy materials delivered during well child visits by pediatric residents focusing on satiety cues, sweetened beverages, introduction of solids, portion sizes, non-sedentary activity, and breastfeeding | - BMI at 2 years |