Dietary Behavior Clinical Trial
Official title:
Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later. The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program. The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include 1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program. 2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have 1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily. 2. Availability of fruit, vegetable, and whole grain in the home pantry. 3. Number of lunches with temperature in the safe range at time of service.
Lunch is in the Bag is a behaviorally-based, multilevel intervention to increase the availability of fruits, vegetables and whole grains in sack lunches for preschool children. The Lunch is in the Bag program was designed to fit within the limited time available for parents at childcare centers, and includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later. The primary aim of this proposal is to determine if Lunch is in the Bag program improves the nutrient composition of sack lunches parents pack for children. The primary hypothesis for this aim: - At 6-week and 28-week follow-up periods, compared to children's lunches at the comparison centers, children's lunches in the intervention group will, on average, contain more servings of: a) fruit; b) vegetables; c) whole grains. The secondary hypotheses for this aim: 1. At 6-week and 28-week follow-up periods, compared to children's lunches at the comparison centers, children's lunches at the intervention centers on average will have higher dietary quality relative to the Dietary Reference Intakes (DRI) for energy, dietary fiber, carbohydrate, saturated fat, trans fat, vitamin A, calcium, iron, and zinc. 2. At 28-week follow-up periods, children at intervention centers will have smaller increase in BMI compared to children in comparison centers. The secondary aim of this study is to examine effects of the intervention on psychosocial, behavioral, and environmental supports in the child's home environment. Hypotheses for this aim: At 6-week and 28-week follow-up periods, 1. Compared to children at the comparison centers, children at the intervention centers on average will have greater frequency of eating fruits, vegetables, and whole grain foods at home. 2. Compared to parents of children at the comparison centers, parents of children at the intervention centers on average will have greater 1. Behavioral capability/knowledge, perceived behavioral control/self-efficacy, expected benefits/attitudes, subjective norms/social support, and intentions for packing fruit, vegetable, and whole grain in the child's lunch sack daily. 2. Amount of parent-child cooperation in lunch packing decisions and behaviors. 3. Availability of fruit, vegetable, and whole grain in the home pantry. 4. Number of lunches with temperature in the safe range at time of service. Additional aims include the evaluation of factors affecting implementation and adaption of the program. Childcare centers (n=40) that require parents to send sack lunches from home will be randomized to intervention and control groups. Families (n=800) will be enrolled as parent-child dyads comprised of the primary lunch packer and one 3 to 5 year old child per family. Outcome measures will be assessed at (1) baseline, (2) immediately after the five-week intervention (6 weeks), (3) 3 months later immediately before a "booster" activity (23 weeks), and (4) 5 weeks after the booster (28 weeks). Mediation analyses will be guided by the Theory of Planned Behavior (TPB) and Social Cognitive Theory (SCT), with particular attention to the reciprocal influences of the child's eating behavior and the parent's food packing behavior and perceptions of child food preferences. Qualitative and process data collection will be conducted throughout the intervention. Data from this study will enable us to determine the efficacy and feasibility of a parent-based intervention implemented through childcare centers to increase the availability of fruits, vegetables, and whole grains in diets of preschool children. The ultimate goal for this work is the development of new strategies for the promotion of healthy eating practices in children through childcare centers, which will decrease their risk of cancer and other chronic diseases later in life. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05276479 -
Dietary Plant Hormone and Mental Health
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