Depression, Obesity, Overweight
Conditions
Keywords
Feeding practices, Diet, Physical activity, Prevention
Brief summary
The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.
Detailed description
Background: Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching). Overweight, defined as a BMI \> 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% at risk of overweight, defined as a BMI \> 85th percentile (Ogden et al., 2006). Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight. Purpose of Study: The investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions. The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth. In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.
Interventions
At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
Sponsors
Study design
Eligibility
Inclusion criteria
* At least 18 yrs old * Has child between 12-32 months * Child able to walk * Birth weight of child at least 5lbs. 8oz.
Exclusion criteria
* Mom cannot be pregnant * No known congenital problems or disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Body Mass Index (BMI) Z-score for Toddlers | Baseline to 12-month Follow-up | Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese. |
| Change in Body Mass Index (BMI) Score Among Mothers | Baseline to 12 month Follow-up | Change body mass index (BMI, kg/m\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Diet Quality for Mothers | Baseline to 12-month Follow-up | Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal |
| Change of Child Physical Activity | Baseline to 12-month Follow-up | Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity. |
| Feeding Style | Baseline to 12 month Follow-up | The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability \>0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks. |
| Change of Maternal Physical Activity | Baseline-12 month follow up | Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity. |
| Change of Diet Quality for Toddlers | Baseline to 12-month Follow-up | Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) A maternal lifestyle intervention focusing on healthy diet and physical activity patterns for mothers.
Maternal Lifestyle (Physical Activity and Nutrition): At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends. | 94 |
| Responsive Parenting A responsive parenting intervention focusing on parenting, limit setting, and development strategies.
Responsive Parenting: Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development. | 92 |
| Child Safety Attention control group. The parents received intervention to promote safety among toddlers.
Child Safety: The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals. | 91 |
| Total | 277 |
Baseline characteristics
| Characteristic | Maternal Lifestyle (Physical Activity and Nutrition) | Responsive Parenting | Child Safety | Total |
|---|---|---|---|---|
| Age, Continuous | 26.17 years STANDARD_DEVIATION 5.9 | 27.53 years STANDARD_DEVIATION 6.5 | 28.16 years STANDARD_DEVIATION 5.99 | 27.28 years STANDARD_DEVIATION 6.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 92 Participants | 88 Participants | 272 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Household Poverty Ratio | 68 Participants | 59 Participants | 58 Participants | 185 Participants |
| Location (Urban/Semi-Urban) | 56 Participants | 58 Participants | 53 Participants | 167 Participants |
| Maternal age | 26.17 years STANDARD_DEVIATION 5.9 | 27.53 years STANDARD_DEVIATION 6.5 | 28.16 years STANDARD_DEVIATION 5.99 | 27.28 years STANDARD_DEVIATION 6.17 |
| Maternal BMI | 31.98 kg/m^2 STANDARD_DEVIATION 9.48 | 31.90 kg/m^2 STANDARD_DEVIATION 9.78 | 31.51 kg/m^2 STANDARD_DEVIATION 9.24 | 31.80 kg/m^2 STANDARD_DEVIATION 9.47 |
| Maternal dietary intake | 2281 kcal/day STANDARD_DEVIATION 745 | 2214 kcal/day STANDARD_DEVIATION 1053 | 2033 kcal/day STANDARD_DEVIATION 738 | 2177 kcal/day STANDARD_DEVIATION 859 |
| Maternal Education | 74 Participants | 75 Participants | 75 Participants | 224 Participants |
| Maternal Marital Status | 24 Participants | 25 Participants | 29 Participants | 78 Participants |
| Maternal physical activity | 23.22 Minutes Mod/Vig Activity/Day STANDARD_DEVIATION 18.07 | 26.14 Minutes Mod/Vig Activity/Day STANDARD_DEVIATION 20.36 | 27.52 Minutes Mod/Vig Activity/Day STANDARD_DEVIATION 17.82 | 25.54 Minutes Mod/Vig Activity/Day STANDARD_DEVIATION 18.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants | 67 Participants | 62 Participants | 193 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 6 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 21 Participants | 19 Participants | 22 Participants | 62 Participants |
| Region of Enrollment United States | 94 participants | 92 participants | 91 participants | 277 participants |
| Sex: Female, Male Female | 94 Participants | 92 Participants | 91 Participants | 277 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Toddler age | 19.98 months STANDARD_DEVIATION 5.55 | 20.22 months STANDARD_DEVIATION 5.56 | 20.14 months STANDARD_DEVIATION 5.46 | 20.11 months STANDARD_DEVIATION 5.5 |
| Toddler Body Mass Index (BMI) Z-score | 0.49 Body mass index z-scores STANDARD_DEVIATION 1.1 | 0.51 Body mass index z-scores STANDARD_DEVIATION 1.16 | 0.63 Body mass index z-scores STANDARD_DEVIATION 1.14 | 0.54 Body mass index z-scores STANDARD_DEVIATION 1.13 |
| Toddler dietary intake | 1282 Total energy kcal/day STANDARD_DEVIATION 476 | 1297 Total energy kcal/day STANDARD_DEVIATION 463 | 1262 Total energy kcal/day STANDARD_DEVIATION 419 | 1281 Total energy kcal/day STANDARD_DEVIATION 453 |
| Toddler physical activity | 45.45 Minutes Mod/Vig physical activity/day STANDARD_DEVIATION 38.53 | 52.99 Minutes Mod/Vig physical activity/day STANDARD_DEVIATION 35.87 | 64.62 Minutes Mod/Vig physical activity/day STANDARD_DEVIATION 45.16 | 54.08 Minutes Mod/Vig physical activity/day STANDARD_DEVIATION 40.43 |
| Toddler race/ethnicity Hispanic | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Toddler race/ethnicity Mixed | 7 Participants | 6 Participants | 4 Participants | 17 Participants |
| Toddler race/ethnicity Non-Hispanic African American | 64 Participants | 67 Participants | 62 Participants | 193 Participants |
| Toddler race/ethnicity Non-Hispanic White | 21 Participants | 19 Participants | 22 Participants | 62 Participants |
| Toddler sex Females | 48 Participants | 37 Participants | 45 Participants | 130 Participants |
| Toddler sex Males | 46 Participants | 55 Participants | 46 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 92 | 0 / 91 |
| other Total, other adverse events | 0 / 94 | 0 / 92 | 0 / 91 |
| serious Total, serious adverse events | 0 / 94 | 0 / 92 | 0 / 91 |
Outcome results
Change in Body Mass Index (BMI) Score Among Mothers
Change body mass index (BMI, kg/m\^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.
Time frame: Baseline to 12 month Follow-up
Population: Mothers of toddlers participating in study, low-income, defined as WIC-eligible.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at baseline | 31.98 kg/m^2 | Standard Deviation 0.98 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at 12-month follow-up | 32.22 kg/m^2 | Standard Deviation 0.99 |
| Responsive Parenting | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at baseline | 31.90 kg/m^2 | Standard Deviation 0.99 |
| Responsive Parenting | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at 12-month follow-up | 32.21 kg/m^2 | Standard Deviation 0.99 |
| Child Safety | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at baseline | 31.51 kg/m^2 | Standard Deviation 0.99 |
| Child Safety | Change in Body Mass Index (BMI) Score Among Mothers | Maternal BMI at 12-month follow-up | 31.85 kg/m^2 | Standard Deviation 1 |
Change of Body Mass Index (BMI) Z-score for Toddlers
Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
Time frame: Baseline to 12-month Follow-up
Population: Toddlers in low-income families, defined as WIC-eligible (income \< 185% of poverty index). WIC=Special Supplementary Program for Women, Infants, and Children.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddlers BMI z-score at baseline | 0.49 z-score | Standard Error 0.12 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddler BMI z-score12-month follow-up | 0.52 z-score | Standard Error 0.12 |
| Responsive Parenting | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddlers BMI z-score at baseline | 0.50 z-score | Standard Error 0.12 |
| Responsive Parenting | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddler BMI z-score12-month follow-up | 0.61 z-score | Standard Error 0.12 |
| Child Safety | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddlers BMI z-score at baseline | 0.62 z-score | Standard Error 0.12 |
| Child Safety | Change of Body Mass Index (BMI) Z-score for Toddlers | Toddler BMI z-score12-month follow-up | 0.57 z-score | Standard Error 0.12 |
Change of Child Physical Activity
Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Time frame: Baseline to 12-month Follow-up
Population: Toddlers who participated in the trial, from low-income families, defined as WIC-eligible
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Child Physical Activity | Toddler MVPA at baseline | 44.56 minutes per day | Standard Error 4.92 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Child Physical Activity | Toddler MVPA at 12-month follow | 73.10 minutes per day | Standard Error 7.37 |
| Responsive Parenting | Change of Child Physical Activity | Toddler MVPA at baseline | 52.39 minutes per day | Standard Error 4.98 |
| Responsive Parenting | Change of Child Physical Activity | Toddler MVPA at 12-month follow | 71.05 minutes per day | Standard Error 7.13 |
| Child Safety | Change of Child Physical Activity | Toddler MVPA at baseline | 64.18 minutes per day | Standard Error 5.11 |
| Child Safety | Change of Child Physical Activity | Toddler MVPA at 12-month follow | 69.05 minutes per day | Standard Error 7.14 |
Change of Diet Quality for Mothers
Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
Time frame: Baseline to 12-month Follow-up
Population: Mothers of toddlers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Diet Quality for Mothers | Baseline HEI 2015 | 46.88 score on a scale | Standard Error 1.32 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Diet Quality for Mothers | 12-month HEI 2015 | 48.39 score on a scale | Standard Error 1.52 |
| Responsive Parenting | Change of Diet Quality for Mothers | Baseline HEI 2015 | 48.71 score on a scale | Standard Error 1.35 |
| Responsive Parenting | Change of Diet Quality for Mothers | 12-month HEI 2015 | 46.90 score on a scale | Standard Error 1.53 |
| Child Safety | Change of Diet Quality for Mothers | Baseline HEI 2015 | 48.52 score on a scale | Standard Error 1.34 |
| Child Safety | Change of Diet Quality for Mothers | 12-month HEI 2015 | 46.74 score on a scale | Standard Error 1.57 |
Change of Diet Quality for Toddlers
Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.
Time frame: Baseline to 12-month Follow-up
Population: Change in HEI 2015 score for toddlers from baseline to 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Diet Quality for Toddlers | Toddler HEI total at baseline | 52.44 units on a scale | Standard Error 1.18 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Diet Quality for Toddlers | Toddler HEI total at 12-month follow-up | 52.84 units on a scale | Standard Error 1.38 |
| Responsive Parenting | Change of Diet Quality for Toddlers | Toddler HEI total at baseline | 54.58 units on a scale | Standard Error 1.2 |
| Responsive Parenting | Change of Diet Quality for Toddlers | Toddler HEI total at 12-month follow-up | 52.49 units on a scale | Standard Error 1.36 |
| Child Safety | Change of Diet Quality for Toddlers | Toddler HEI total at baseline | 55.1 units on a scale | Standard Error 1.19 |
| Child Safety | Change of Diet Quality for Toddlers | Toddler HEI total at 12-month follow-up | 52.19 units on a scale | Standard Error 1.35 |
Change of Maternal Physical Activity
Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Time frame: Baseline-12 month follow up
Population: Change in the number of steps per day from baseline to 12-month follow-up in MVPA
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Maternal Physical Activity | Maternal MVPA at baseline | 23.10 minutes per day | Standard Error 2.06 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Change of Maternal Physical Activity | Maternal MVPA at 12-month follow | 27.41 minutes per day | Standard Error 3.07 |
| Responsive Parenting | Change of Maternal Physical Activity | Maternal MVPA at 12-month follow | 20.42 minutes per day | Standard Error 3.21 |
| Responsive Parenting | Change of Maternal Physical Activity | Maternal MVPA at baseline | 26.11 minutes per day | Standard Error 2.17 |
| Child Safety | Change of Maternal Physical Activity | Maternal MVPA at baseline | 27.76 minutes per day | Standard Error 2.17 |
| Child Safety | Change of Maternal Physical Activity | Maternal MVPA at 12-month follow | 21.09 minutes per day | Standard Error 3.22 |
Feeding Style
The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability \>0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.
Time frame: Baseline to 12 month Follow-up
Population: Change in Emotional Availability Scale scores from baseline to 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Lifestyle (Physical Activity and Nutrition) | Feeding Style | Maternal feeding style at baseline | 4.69 score on a scale | Standard Error 0.11 |
| Maternal Lifestyle (Physical Activity and Nutrition) | Feeding Style | Maternal feeding style at 12-month | 5.07 score on a scale | Standard Error 0.14 |
| Responsive Parenting | Feeding Style | Maternal feeding style at baseline | 4.42 score on a scale | Standard Error 0.11 |
| Responsive Parenting | Feeding Style | Maternal feeding style at 12-month | 5.19 score on a scale | Standard Error 0.14 |
| Child Safety | Feeding Style | Maternal feeding style at baseline | 4.71 score on a scale | Standard Error 0.12 |
| Child Safety | Feeding Style | Maternal feeding style at 12-month | 5.46 score on a scale | Standard Error 0.13 |