Childhood Obesity
Conditions
Brief summary
Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.
Interventions
BEHAVIORALm-health approach
Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981). Anthropometric and demographic data collected on children in the dyad only.
Sponsors
Southeastern Louisiana University
Pennington Biomedical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
for Child: * Have at least one participating parent * Be physically capable of exercise * Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer Inclusion Criteria for Parent: * Have a smart phone * Be willing to use the smartphone for the mHealth intervention
Exclusion criteria
for Child: * Significant cardiovascular disease or disorders via self-report from parent * Other significant medical problems that would prevent them from engaging in regular physical activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Acceptability of the mHealth Approach | 13 Weeks | Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI Z-score Change | Week 0 to Week 14-16 | Objectively measured height and weight were compared against the normative values for age (months) and sex according to the CDC growth charts. A z-score is assigned, with 0 representing the population mean. A positive z-score indicates a BMI above the population mean (higher relative weight), whereas a negative z-score is below the population mean (lower relative weight). For the change score, the post BMI z-score measured at week 14-16 was subtracted from the baseline BMI z-score. For the change score, a positive value indicates an increase in relative weight, whereas a negative value indicates a reduction in relative weight. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Child Participants in the Dyads All dyads will receive the m-health approach.
m-health approach: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981). | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Child Participants in the Dyads |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 7.8 years STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Child Acceptability of the mHealth Approach
Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability.
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-health Approach | Child Acceptability of the mHealth Approach | 3.8 score on a scale | Standard Deviation 0.5 |
Secondary
BMI Z-score Change
Objectively measured height and weight were compared against the normative values for age (months) and sex according to the CDC growth charts. A z-score is assigned, with 0 representing the population mean. A positive z-score indicates a BMI above the population mean (higher relative weight), whereas a negative z-score is below the population mean (lower relative weight). For the change score, the post BMI z-score measured at week 14-16 was subtracted from the baseline BMI z-score. For the change score, a positive value indicates an increase in relative weight, whereas a negative value indicates a reduction in relative weight.
Time frame: Week 0 to Week 14-16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-health Approach | BMI Z-score Change | -0.14 Z-Score | Standard Deviation 0.17 |