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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biweekly Arm | Experimental | 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly. |
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| Monthly Arm | Experimental | 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly. |
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| Weekly | Experimental | 6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group nutrition sessions | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Evaluation of participant attendance in each arm. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen A Copeland | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9085394 | Background | Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134. |
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This was a small, iterative feasibility study as a precursor to a larger clinical trial.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biweekly Arm | 13 parent-child dyads were enrolled in this arm which convened biweekly. |
| FG001 | Monthly Arm | 12 parent-child dyads were enrolled in this arm which convened monthly. |
| FG002 | Weekly Arm | 8 parent-child dyads were enrolled in this arm which convened weekly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Attendance | Evaluation of participant attendance in each arm. | Posted | Count of Participants | Participants | Baseline, 3 months |
|
12 months
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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 | Biweekly Arm | 12 parent-child dyads participated in the biweekly arm which convened for 6 sessions. |
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Small number of subjects analyzed. Difficulty recruiting and retaining engaged participants for collection of all desired outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Kristen Copeland | Cincinnati Children's Hospital Medical Center | 5136361687 | kristen.copeland@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2018 | Apr 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2018 | Aug 29, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Fitbit | Device | 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. |
|
| 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. | Baseline, 3 months |
| 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. | baseline, 3 months |
| 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 | Baseline, 3 months |
| 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. | baseline, 3 months |
| 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. | Baseline, 3 months |
| Physician Decision |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
|
|
| 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. | 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. | Posted | Baseline, 3 months |
|
|
| 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. | PEDS QL was only administered to the Biweekly Arm. | Posted | Mean | Full Range | score on a scale | Baseline, 3 months |
|
|
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| 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. | Due to recruitment and retention issues, BMI Z-score was not evaluated for the weekly arm. | Posted | Mean | Standard Deviation | score | Baseline, 3 months |
|
|
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| 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. | The results for overall satisfaction are listed under outcome #2 under primary outcomes. | Posted | baseline, 3 months |
|
|
| 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 | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | baseline, 3 months |
|
|
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| 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. | 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. | Posted | Baseline, 3 months |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Monthly Arm | 8 parent-child dyads participated in the biweekly arm which convened for 6 sessions. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Weekly Arm | 6 parent-child dyads participated in the biweekly arm which convened for 6 sessions. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |