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| Name | Class |
|---|---|
| Southeastern Louisiana University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| m-health approach | Experimental | All dyads will receive the m-health approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| m-health approach | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Child:
Inclusion Criteria for Parent:
Exclusion Criteria for Child:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Staiano, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Corby Martin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Louisiana University | Hammond | Louisiana | 70402 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33410760 | Derived | Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714. |
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| ID | Title | Description |
|---|---|---|
| FG000 | M-health Approach | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Characteristics data were collected from the children in the dyads only.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 13 Weeks |
|
16 Weeks
Children & Parents in dyads;
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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A limitation of these studies is the one-arm design without a control or comparator and the need for further verification in a larger randomized controlled trial. It is possible that BMIz fluctuations were influenced by maturation bias or regression to the mean, though the observed effect size was similar to prior interventions. Another limitation is the use of BMIz to examine change, as researchers have identified concerns with z-score for children with a BMI above the 97th percentile.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Staiano | LSU's Pennington Biomedical Research Center | 2257632500 | amanda.staiano@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2017 | Jun 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2017 | Aug 16, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2017 | Aug 16, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| Week 0 to Week 14-16 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| 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. | Posted | Mean | Standard Deviation | Z-Score | Week 0 to Week 14-16 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Parent 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). | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |