Obesity
Conditions
Brief summary
The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.
Detailed description
In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time
Interventions
BEHAVIORALGroup nutrition sessions
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
DEVICEFitbit
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay) * BMI is greater than 85th%ile for age and sex * English speaking * have access to a computer/internet or a smart phone (for uploading Fitbit data)
Exclusion criteria
* Have been seen in a weight management clinic within the last 2 years * prescribed an atypical antipsychotic * non-ambulatory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | Baseline, 3 months | Evaluation of participant attendance in each arm. |
| Overall Satisfaction With Group Nutrition Sessions | Baseline, 3 months | Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction. |
| Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens. | Baseline, 3 months | Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Self-efficacy Related to Physical Activity | Baseline, 3 months | Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale. The range of values is 1 to 5, with lower values indicating higher self-efficacy |
| PedsQL (Pediatric Quality of Life Inventory) | Baseline, 3 months | Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life. |
| Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily | Baseline, 3 months | Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention. |
| Child Intention to be Active | baseline, 3 months | Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al. This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active. |
| BMI Z-Score | Baseline, 3 months | BMI Z-scores compares child to age and sex matched peers. A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles. Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population. |
| Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale) | baseline, 3 months | The description of the overall satisfaction variable is described in outcome #2 under primary outcomes. |
Countries
United States
Participant flow
Recruitment details
A total of 36 parent-child dyads (72 individual participants) were consented and enrolled over the entire course of the study starting with recruitment in February 2016 and ending with the final session in July 2018.
Participants by arm
| Arm | Count |
|---|---|
| Biweekly Arm The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the first of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered biweekly (first phase).Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session. | 12 |
| Monthly Arm The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the second of three non-concurrent phases of the study which sought to compare the feasibility and efficacy of the group sessions when offered monthly (second phase). Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session. | 8 |
| Weekly Arm The intervention consisted of 6 nutrition group sessions co-led by parent and a professional from the community who rotated at each session. Group nutrition sessions consisted of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. This is the third of three non-concurrent phases of the study which sought to compare the feasibility of the group sessions when offered weekly (third phase). For phases one and two participants will participate in only one phase. Due to recruitment issues in the third phase, researchers obtained IRB approval to allow participants from previous phases to participate and instead evaluated feasibility outcomes. Parent and child dyads in each arm and phase received a Fitbit Flex wearable device at the second session. | 6 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Monthly Arm | Weekly Arm | Total | Biweekly Arm |
|---|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 6 Participants | 26 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8 years STANDARD_DEVIATION 2 | 11 years STANDARD_DEVIATION 2 | 10 years STANDARD_DEVIATION 2 | 10 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 8 Participants | 6 Participants | 26 Participants | 12 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 12 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Attendance
Evaluation of participant attendance in each arm.
Time frame: Baseline, 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 5 | 11 Participants |
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 3 | 8 Participants |
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 4 | 10 Participants |
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 6 | 8 Participants |
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 2 | 12 Participants |
| Biweekly Arm | Attendance | Number of Participants in Attendance at Session 1 | 11 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 3 | 7 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 1 | 8 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 2 | 8 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 4 | 4 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 5 | 6 Participants |
| Monthly Arm | Attendance | Number of Participants in Attendance at Session 6 | 5 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 2 | 2 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 6 | 6 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 5 | 4 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 3 | 3 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 1 | 2 Participants |
| Weekly Arm | Attendance | Number of Participants in Attendance at Session 4 | 6 Participants |
Primary
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Time frame: Baseline, 3 months
Population: Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Primary
Overall Satisfaction With Group Nutrition Sessions
Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biweekly Arm | Overall Satisfaction With Group Nutrition Sessions | 4.82 score on a scale |
| Monthly Arm | Overall Satisfaction With Group Nutrition Sessions | 4.68 score on a scale |
| Weekly Arm | Overall Satisfaction With Group Nutrition Sessions | 4.79 score on a scale |
Secondary
BMI Z-Score
BMI Z-scores compares child to age and sex matched peers. A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles. Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
Time frame: Baseline, 3 months
Population: Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biweekly Arm | BMI Z-Score | 1.84 score | Standard Deviation 0.43 |
| Monthly Arm | BMI Z-Score | 2.15 score | Standard Deviation 0.41 |
Secondary
Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Time frame: Baseline, 3 months
Population: Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Secondary
Child Intention to be Active
Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al. This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
Time frame: baseline, 3 months
Population: This measure was administered at 3 months in biweekly arm and monthly arm, but not administered in weekly arm. All completed subjects contributed data in biweekly arm; 7 subjects contributed data for monthly arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biweekly Arm | Child Intention to be Active | Baseline | 4.00 score on a scale |
| Biweekly Arm | Child Intention to be Active | 3 months | 4.00 score on a scale |
| Monthly Arm | Child Intention to be Active | Baseline | 4.00 score on a scale |
| Monthly Arm | Child Intention to be Active | 3 months | 4.50 score on a scale |
Secondary
Child Self-efficacy Related to Physical Activity
Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale. The range of values is 1 to 5, with lower values indicating higher self-efficacy
Time frame: Baseline, 3 months
Population: This measure was administered at 3 months in biweekly arm and monthly arm, but not administered in weekly arm. All completed subjects contributed data in biweekly arm; 7 subjects contributed data for monthly arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biweekly Arm | Child Self-efficacy Related to Physical Activity | Baseline | 1.71 score on a scale |
| Biweekly Arm | Child Self-efficacy Related to Physical Activity | 3 months | 1.71 score on a scale |
| Monthly Arm | Child Self-efficacy Related to Physical Activity | Baseline | 2.07 score on a scale |
| Monthly Arm | Child Self-efficacy Related to Physical Activity | 3 months | 1.43 score on a scale |
Secondary
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
Time frame: baseline, 3 months
Population: The results for overall satisfaction are listed under outcome #2 under primary outcomes.
Secondary
PedsQL (Pediatric Quality of Life Inventory)
Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
Time frame: Baseline, 3 months
Population: PEDS QL was only administered to the Biweekly Arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biweekly Arm | PedsQL (Pediatric Quality of Life Inventory) | Baseline | 72 score on a scale |
| Biweekly Arm | PedsQL (Pediatric Quality of Life Inventory) | 3 months | 74 score on a scale |