Obesity, Childhood
Conditions
Keywords
obesity, young children, feeding practices, obesity prevention, obesity intervention, child feeding questionnaire, satiety responsiveness, food responsiveness, family meal frequency questionnaire, structure of family meals
Brief summary
The goal of this qualitative trial study is to assess the usefulness and acceptability of the intervention in diverse clinical and community settings. The main questions it aims to answer are: * How many parents were approached and consented to participate? * How many parents viewed the videos via link versus viewed the video with a discussion in group sessions? * How did parents feel about the process of being recruited and interventions that they participated in? * How did the providers feel about the intervention recruitment and delivery? * How did the facilitators feel about their delivery of the material? Participants will complete a survey and an interview after completing second part of the intervention. Researchers will compare handout, online-only video, and group class interventions to see if an intervention delivery is useful and accepted by parents or providers.
Detailed description
This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study will recruit 30 parents. Parents will be randomized to the control group or 1 of 2 intervention delivery approaches (IA). Parents will be given a handout (controls), links to the videos to watch independently (IA 1), or information on how they will be contacted to schedule their intervention sessions (IAs 2). After 2 video/sessions, all parents will complete a written survey assessing their experience with the intervention and any change same at home; the written survey will reassess baseline measures. Intervention parents will also complete a semi-structured interview to assess the experience with the STORY trial. Sub aim 2a: Feasibility: number of parents approached, number of parents consented Sub aim 2b: Adherence: number of parents who complete videos or sessions Sub aim 2c: Acceptability to parents and providers
Interventions
Educational handout describing responsive feeding practices.
Videos geared toward responsive feeding practices.
Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.
Sponsors
Study design
Eligibility
Inclusion criteria
* Parent of 2-4 year old child * Is at least 18 years old * Participant can read and write English * The participant's child has no medical conditions that affect development, feeding, or growth
Exclusion criteria
* Participant is not a parent of a 2-4 year old child * Parent is less than 18 years old * Parent can not read and write English * Participant's child has a medical condition that affects development, feeding, or growth * Family/household member participating in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Parents Approached | Baseline | Number of parents who are approached for participation at 3 primary care offices. |
| Number of Parents Consented | Baseline | Number of parents that consented to participating in the study. |
| Number of Parents Who Viewed Videos Provided by Provider | Month 2 | tracking the number of videos viewed by each parent |
| Number of Parents Who Complete In-Person Group Sessions | Month 2 | number of parents who complete two in-person group sessions |
| Parent Acceptance of Intervention - Percent of Parents | Month 4 | Percent of parents who responded that the intervention was acceptable or completely acceptable to them |
| Facilitator Acceptance of Intervention - Percent of Facilitators | Month 4 | Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pressure to Eat Score (Child Feeding Questionnaire) | Month 4 | The 4-item subscale from the Child Feeding Questionnaire, called Pressure to Eat, measures parents' tendency to pressure their children to eat more food, typically at mealtimes. Possible scores range from 1-5, with higher scores indicating greater severity of parents' tendency to pressuring their children to eat more food. Information to be utilized in a future larger study. |
| Mean Restriction Score (Child Feeding Questionnaire) | Month 4 | The 8-item subscale from the Child Feeding Questionnaire, called Restriction, measures the extent to which parents restrict their child's access to foods. Possible scores range from 1-5, with higher scores indicating greater severity of parents restricting their child's access to foods. Information to be utilized in a future larger study. |
| Mean Satiety Responsiveness Score | Month 4 | Mean satiety responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores indicating higher self-regulation. Information to be utilized in a future larger study. |
| Mean Food Responsiveness Score | Month 4 | Mean food responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study. |
| Mean Enjoyment of Food Score | Month 4 | Mean enjoyment of food score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study. |
| Mean of Families Using Structured Mealtime Practices | Month 4 | The 10-item Structure of Family Meals subscale from the Meals in our Household Questionnaire measures how often families spend their mealtimes in a specific setting. Possible scores range from 0-4, with higher scores indicating higher occurrences of specific mealtime settings. Information to be utilized in a future larger study. |
| Percentage of Families Eating Family Meals at Least 3 Times Per Week | Month 4 | Percentage of families eating family meals at least 3 times per week using Family Meal Frequency Questionnaire which asks how many times a week the family eats dinner together, both at home and at a restaurant. Information to be utilized in a future larger study. |
| Fidelity of Intervention Delivery - Percentage of Key Points | month 4 | Study staff will complete Evaluation Checklist of 9 essential key points communicated during each group session to determine intervention delivery. Out of the possible 18 key points the percentage of key points communicated during the sessions will be tallied. |
| Facilitator Self-Competence Percentage - Percentage of Facilitators | month 4 | Percentage of facilitators who respond Agree or Strongly Agree to survey question about perceived self-competence |
| Fidelity of Receipt - Percentage of Parents | month 4 | Percentage of parents who respond Agree or Strongly Agree to survey question about whether the video content was relevant |
| Percentage of Parents Who Identified a Goal | month 4 | Receipt will be collected through the follow-up survey. Information collected includes a response of "yes" or "no" by parent expert assessment of whether the parent identified an attainable, specific, and measurable goal. Percentage of parents who identified a goal will include the percentage who answer "yes". |
| Enactment Percentage | month 4 | Enactment will be collected through the follow-up survey. Enactment Percentage will include those considered by an expert to have made a specific and measurable change in feeding practices. |
Countries
United States
Contacts
Wake Forest University Health Sciences
Participant flow
Recruitment details
Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
Pre-assignment details
Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| High School Education High school graduate | 15 Participants |
| High School Education Less than high school diploma | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |