Feeding Behavior, Obesity, Childhood
Conditions
Keywords
early childhood, family, occupational therapy
Brief summary
This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition.
Detailed description
Children have not been spared from the obesity epidemic. There is a great need for innovative interventions to help families build healthy habits early in life for obesity prevention. Low-income preschoolers have a disproportionately high rate of childhood obesity, and their families face complex barriers to healthy behavior change. This proposed pilot study will examine the feasibility of delivering the Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) intervention in a sample of low-income families with young children (ages 2-5). Our parent-mediated intervention is designed to promote healthy dietary variety using routine family meals, positive reinforcement, social modeling, and food exploration and play. By harnessing the behavior change capacity of behavioral activation to alter daily mealtimes incrementally, parents are empowered to overcome barriers to healthy habit formation. Each family will participate in a six-week intervention that is delivered by occupational therapy clinicians in the home environment. Each session will last approximately one hour and include individualized parent-training and a parent-led mealtime with direct feedback from the clinician. We planned to screen up to 100 potential parent and child participants, with a plan to deliver intervention to 20 child participants.
Interventions
BEHAVIORALMealtime PREP Intervention
Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines.
Sponsors
National Institutes of Health (NIH)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Repeated Measures
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Child: * within age range 2-5 years * reside in a low-income household (as specified by income within the range to qualify for Special Supplemental Nutrition Program for Women, Infants, and Children. Parent: * \>18 years old * ability to read and speak in English * willing to participate in 6 home-based intervention sessions
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months | baseline and 3 months | The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months | Baseline, 3 months | 36 item scale validated in a sample of low-income families with preschoolers to assess parental stress in three domains and overall. Raw scores are converted to percentiles for interpretation using this tool. For the total parenting stress score, and all three domain scores (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child), higher percentiles are interpreted as higher stress (range =1-99%) with scores \>90% indicating clinically significant levels of parenting stress. We are reporting the Total parenting stress score. |
| Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months | baseline and 3 months | 17 item, validated screen for young children (1-5 years) that categorizes risk of nutritional problems into 3 categories (score range = 1 (minimum) - 68 (maximum); 1 - 20 = low risk, 21-25 = moderate risk, and 26+ = high risk). Higher scores indicate higher risk for nutritional problems (i.e. lower scores are better). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between February and June of 2019 using research registry (Pitt + Me) and in the community at WIC (Supplemental Nutrition for Women, Infants and Children) program sites.
Participants by arm
| Arm | Count |
|---|---|
| Mealtime PREP Intervention Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.
Mealtime PREP Intervention: Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Mealtime PREP Intervention |
|---|---|
| 3-Day Food Diary | 19 number of unique foods STANDARD_DEVIATION 5 |
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 43.76 months STANDARD_DEVIATION 12.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nutrition Screening Tool for Every Preschooler | 22.90 units on a scale STANDARD_DEVIATION 8.94 |
| Parenting Stress Index - Short Form | 75.67 units on a scale STANDARD_DEVIATION 30.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months
The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up.
Time frame: baseline and 3 months
Population: We only received completed 3-Day Food Diaries from three participants at both baseline and the 3-month follow-up time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mealtime PREP Intervention | Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months | 3.66 number of unique foods | Standard Deviation 2.08 |
Secondary
Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months
17 item, validated screen for young children (1-5 years) that categorizes risk of nutritional problems into 3 categories (score range = 1 (minimum) - 68 (maximum); 1 - 20 = low risk, 21-25 = moderate risk, and 26+ = high risk). Higher scores indicate higher risk for nutritional problems (i.e. lower scores are better).
Time frame: baseline and 3 months
Population: 5 participants lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mealtime PREP Intervention | Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months | -2.80 score on a scale | Standard Deviation 5.43 |
Comparison: After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.p-value: <0.01t-test, 2 sided
Secondary
Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months
36 item scale validated in a sample of low-income families with preschoolers to assess parental stress in three domains and overall. Raw scores are converted to percentiles for interpretation using this tool. For the total parenting stress score, and all three domain scores (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child), higher percentiles are interpreted as higher stress (range =1-99%) with scores \>90% indicating clinically significant levels of parenting stress. We are reporting the Total parenting stress score.
Time frame: Baseline, 3 months
Population: We experienced a significant amount of missing data for the first 8 participants completing this form, which led to an inability to calculate scores for baseline. Research procedures were adjusted, but only had complete data on 9 of 12 remaining participants at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mealtime PREP Intervention | Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months | 0.22 score on a scale | Standard Deviation 25.04 |
Comparison: Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.95% CI: [-0.66, 0.65]