Behavior, Health, Obesity, Childhood, Parent-Child Relations, Weight Change, Body
Conditions
Keywords
weight management, pediatric weight management, mHealth, mobile technology, parent/child relations, dyad
Brief summary
Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.
Detailed description
For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.
Interventions
BEHAVIORALBrenner mFIT (standard care)
Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.
BEHAVIORALBrenner mFIT (standard care plus mobile health components)
Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The control group will receive standard Brenner FIT care. The intervention group will receive standard Brenner FIT care in additional to mobile health components in the hopes of maximizing the benefits that are already seen with pediatric weight management programs like Brenner FIT.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet
Exclusion criteria
Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Percentile | Baseline | The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a healthy weight, over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Via Accelerometry (Bouts of Physical Activity) | Baseline | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. |
| ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | Baseline | To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day). Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges. |
| Economic Costs of the Two Intervention Arms | Through study completion (6 months) | Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant. |
Countries
United States
Participant flow
Recruitment details
Fourteen parent-child dyads provided consent and agreed to participate. In total, 28 participants (14 parents/14 children) were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Brenner FIT (Standard Care) Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments.
Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits. | 14 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) Adolescents will participate in Brenner Families in Training along with their caregiver.
Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT
Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components.
The six mHealth components that will be used in addition to standard Brenner Families in Training program include-
1. a mobile-enabled website,
2. diet and physical activity tracking apps and physical activity tracker
3. tailored self-monitoring feedback
4. caregiver podcasts
5. animated videos for adolescent patients
6. social support via social media. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Brenner mFIT (Standard Care Plus Mobile Health Components) | Brenner FIT (Standard Care) | Total |
|---|---|---|---|
| Age, Continuous Children | 15.0 years STANDARD_DEVIATION 2 | 16.1 years STANDARD_DEVIATION 1.2 | 15.6 years STANDARD_DEVIATION 1.7 |
| Age, Continuous Parents | 36.6 years STANDARD_DEVIATION 4 | 44.7 years STANDARD_DEVIATION 5.2 | 40.6 years STANDARD_DEVIATION 6.1 |
| Body Mass Index percentile | 99.37 BMI percentile for age and sex STANDARD_DEVIATION 0.53 | 98.46 BMI percentile for age and sex STANDARD_DEVIATION 2.39 | 98.91 BMI percentile for age and sex STANDARD_DEVIATION 1.73 |
| Calories consumed per day | 2078.03 kcal/day STANDARD_DEVIATION 889.06 | 2135.27 kcal/day STANDARD_DEVIATION 806.66 | 2106.65 kcal/day STANDARD_DEVIATION 816.1 |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Parents Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Parents Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Parents Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Moderate-to-vigorous physical activity (min/day) | 73.33 Minutes/day STANDARD_DEVIATION 49.14 | 60.75 Minutes/day STANDARD_DEVIATION 54.63 | 66.14 Minutes/day STANDARD_DEVIATION 48.4 |
| Race (NIH/OMB) Children American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Children Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Children More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children White | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Parents American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Parents Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Parents More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents White | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Children Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Children Male | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Parents Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Parents Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
BMI Percentile
The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a healthy weight, over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | BMI Percentile | 98.46 BMI percentile for age and sex | Standard Deviation 2.39 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | BMI Percentile | 99.37 BMI percentile for age and sex | Standard Deviation 0.53 |
Primary
BMI Percentile
The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a healthy weight, over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.
Time frame: 3 months
Population: Zero Participants arrived for their 3 Month Visit due to COVID
Primary
BMI Percentile
The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a healthy weight, over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.
Time frame: 6 months
Population: Data are presented for the three participants who provided data at the six-month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | BMI Percentile | 99 BMI percentile for age and sex | Standard Deviation 1.27 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | BMI Percentile | 99.9 BMI percentile for age and sex | Standard Deviation 0 |
Secondary
ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day). Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 2135.27 Number of Calories (kcal/day) | Standard Deviation 806.66 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 2078.03 Number of Calories (kcal/day) | Standard Deviation 889.06 |
Secondary
ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day). Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Time frame: 3 months
Population: Zero Participants arrived for their 3 Month Visit due to COVID
Secondary
ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day). Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Time frame: 6 months
Population: Three participants in the Standard Care group and no participants in the Standard Care Plus group provided data. Since one group had no participants, no analysis could be performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 1650.6 Number of Calories (kcal/day) | Standard Deviation 679.6 |
Secondary
Economic Costs of the Two Intervention Arms
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Time frame: Through study completion (6 months)
Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brenner FIT (Standard Care) | Economic Costs of the Two Intervention Arms | 2616 US Dollars |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | Economic Costs of the Two Intervention Arms | 3482 US Dollars |
Secondary
Economic Costs of the Two Intervention Arms
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Time frame: Through study completion (6 months)
Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brenner FIT (Standard Care) | Economic Costs of the Two Intervention Arms | 2616 US Dollars |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | Economic Costs of the Two Intervention Arms | 3482 US Dollars |
Secondary
Economic Costs of the Two Intervention Arms
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Time frame: Through study completion (6 months)
Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brenner FIT (Standard Care) | Economic Costs of the Two Intervention Arms | 2,616 US Dollars |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | Economic Costs of the Two Intervention Arms | 3,482 US Dollars |
Secondary
Physical Activity Via Accelerometry (Bouts of Physical Activity)
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Time frame: Baseline
Population: Measure Analysis Population Description: Three participants in the standard care group and four participants in the standard care plus group did not provide valid data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | Physical Activity Via Accelerometry (Bouts of Physical Activity) | 60.75 minutes per day | Standard Deviation 54.63 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | Physical Activity Via Accelerometry (Bouts of Physical Activity) | 73.33 minutes per day | Standard Deviation 49.14 |
Secondary
Physical Activity Via Accelerometry (Bouts of Physical Activity)
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Time frame: 3 months
Population: Zero Participants arrived for their 3 Month Visit due to COVID
Secondary
Physical Activity Via Accelerometry (Bouts of Physical Activity)
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Time frame: 6 months
Population: Two participants in the Standard Care group and one participant in the Standard Care Plus group were provided with accelerometers for the study at six-months follow-up. The participant in the Brenner mFIT did not provide the a minimum of valid days of data (3 or more), so data should be interpreted with caution.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brenner FIT (Standard Care) | Physical Activity Via Accelerometry (Bouts of Physical Activity) | 13.5 Minutes per day | Standard Deviation 5 |
| Brenner mFIT (Standard Care Plus Mobile Health Components) | Physical Activity Via Accelerometry (Bouts of Physical Activity) | 21.0 Minutes per day | Standard Deviation 0 |