C.H.A.M.P. Families: Feasibility of educating parents to treat obesity in their children
| ISRCTN | ISRCTN10752416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10752416 |
| Protocol serial number | Ontario Ministry of Research and Innovation Early Researcher Award (Western University Award ID: R4171A13); Canadian Institutes of Health Research (CIHR) Doctoral Research Award (Competition: 201410MDR, CIHR ID: 336994, Western University Award ID: R4171A15). |
| Sponsor | The Office of Human Research Ethics |
| Funders | Canadian Institutes of Health Research, Ministry of Research, Innovation and Science, Western University |
- Submission date
- 23/04/2018
- Registration date
- 24/04/2018
- Last edited
- 15/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Childhood overweight/obesity is a serious global public health concern. Evidence suggests that the treatment of childhood obesity requires modifying the lifestyle of the entire family. It is important to involve parents to make changes to impact obesity in their children. The purpose of the study was to investigate whether a new parent-focused intervention targeting obesity in children is effective, and whether it is practical to use in the community. The intervention, called "C.H.A.M.P. Families", is an extension of our team’s previous Children’s Health and Activity Modification Program ("C.H.A.M.P."). "C.H.A.M.P. Families" consisted of a 13-week group-based educational intervention for parents of children with overweight/obesity.
Who can participate?
Parents of children aged 6-14 with overweight and obesity in London, Ontario, Canada. Parents were recruited by strategic community advertising, social media, physician referrals, and radio advertisements.
What does the study involve?
Parents of children with overweight/obesity participated in eight 90-minute educational sessions held at a local YMCA over the course of 13 weeks. The parent-focused sessions were designed to address numerous health- and obesity-related topics including physical activity, nutrition, sleep, screen time, sedentary behaviour and screen time, media literacy, and other social/environmental factors (e.g. marketing of unhealthy foods and beverages to children). Goal setting, motivational interviewing, and evidence-based group dynamics strategies were also used to promote lasting behaviour change. At the end of each session, parents were provided with resources, materials, and assigned 'homework' to encourage and support home-based discussions about the weekly topics with children and family goal setting. Finally, 'booster sessions' were held for families (parents, child, and siblings) at 3 and 6 months after the end of the educational sessions. These group-based family sessions include health-related presentations/interactive family activities, social support, and group discussions related to healthy behaviours and choices in the home environment. The C.H.A.M.P. Families program was offered at no cost to participants. Parking was free, and YMCA child minding and drop-in children’s programming were also available free of charge. Data were collected at four timepoints: baseline (≤4 weeks pre-intervention), mid-intervention (Week 6), post-intervention (≤2 weeks post-intervention), and at a 6-month follow-up (June 2018).
What are the possible benefits and risks of participating?
Prior to the start of the study, potential risks for children and parents (e.g. feelings of distress or upset as a result of speaking with other families and learning more about the potential risks of childhood obesity) were identified and shared with participating families. No adverse events related to parents’ or children’s involvement in the program occurred during the study. Potential benefits of the study include improved physical and psychosocial health for both parents and children, increased knowledge related to healthy living, and increased family communication, satisfaction, and cohesion. It is also possible that study participants did not receive any benefits from participation in the study.
Where is the study run from?
C.H.A.M.P. Families was a single-centre study developed and conducted by researchers from The University of Western Ontario in London, Ontario, Canada. The formal 13-week intervention took place at the YMCA of London – Centre Branch in London, Ontario, Canada.
When is the study starting and how long is it expected to run for?
Recruitment started in May 2017 and the 13-week intervention took place from September 2017 to December 2017. Booster session #1 was held in March 2018 and booster session #2 in June 2018.
Who is funding the study?
This project was supported by the Ontario Ministry of Research and Innovation and the Canadian Institutes of Health Research (CIHR).
Who is the main contact?
Principal Investigator: Shauna Burke, PhD (sburke9@uwo.ca)
Project Coordinator/PhD Student: Kristen Reilly, MPH (kreill2@uwo.ca)
Contact information
Scientific
Arthur & Sonia Labatt Health Sciences Building, Rm 337
Western University
London
N6A 5B9
Canada
Public
Elborn College, Room 1021
Western University
1201 Western Road
London
N6G 1H1
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre non-blinded study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | “C.H.A.M.P. Families”: The implementation and evaluation of a parent-focused pilot intervention targeting childhood overweight and obesity |
| Study acronym | C.H.A.M.P. Families |
| Study objectives | The purpose of this study is to implement and evaluate the feasibility of a 13-week parent-focused pilot intervention targeting childhood overweight and obesity. Secondary objectives are to evaluate the effectiveness of the intervention in relation to several important child and family outcomes, including children’s health-related quality of life, children’s general health and wellbeing, children’s physical activity (PA) levels and sedentary time, body mass index for both parents and children, parent-reported family cohesion, communication, and satisfaction, parental self-efficacy related to supporting children’s healthy eating and physical activity behaviours, and children’s and parents’ overall perceptions of the program and its potential impact on their family’s health and wellbeing. |
| Ethics approval(s) | University of Western Ontario Research Ethics Board for Health Sciences Research Involving Human Subjects (HSREB) at the Full Board review level, 15/03/2017, 108826 |
| Health condition(s) or problem(s) studied | Educational intervention targeting parents of children with overweight and obesity. |
| Intervention | Eight 90-minute group-based education sessions were delivered to parents of children with overweight/obesity over the course of 13 weeks (September 18 to December 11, 2017). The program also included two 2-hour family-focused 'booster sessions' for parents and children; one of which was offered 3-months post-intervention (March 2018) and one of which will be offered 6-months post-intervention (June 2018). The formal 13-week intervention took place at a local YMCA facility and covered a broad range of topics related to child and family health, including: 1. Child growth and development 2. Family goal setting 3. Healthy eating and nutrition (e.g. family meals, food skills and literacy, meal planning, grocery shopping, etc) 4. Physical activity (e.g. family-friendly exercises, 24 hour movement guidelines, etc) 5. Sleep and sedentary behaviour (e.g. sleep hygiene, screen time, media literacy, etc) 6. Mental health and wellbeing (e.g. bullying, weight stigma, resilience, etc) 7. Parenting and family dynamics (family cohesion, positive communication, role modeling, etc) 8. Policy issues (e.g. health advocacy, the marketing of unhealthy foods and beverages to children, etc) 9. Community resources. All program sessions were developed by researchers using Social Cognitive Theory constructs (Bandura, 1977; 2004) as a guide, as well as evidence-based strategies grounded in motivational interviewing (Miller & Rollick, 1991) and group dynamics (Carron & Burke, 2005; Forsyth, 2014; Martin et al., 2009). A number of health professionals, experts, and members from community organizations (e.g. Canadian Obesity Network, Heart and Stroke Foundation, Growing Chefs! Ontario, Middlesex-London Health Unit) were featured as guest speakers and delivered relevant content to parents at various sessions throughout the intervention. At the end of each session, parents were provided with evidence-based resources, and were assigned take home activities to encourage, support, and reinforce the concepts discussed in the group setting for at-home use/implementation with children. A portion of some take-home activities were adapted, with permission, from resources used in an evidence-based obesity prevention program for parents of children aged 2-5 years in the United States (i.e. "Homestyles"; Byrd-Bredbenner et al., 2017). In completing the 'homework' activities, parents were asked to engage in weekly discussions about the program topics with children in the home environment and at-home family goal setting related to a specific topic. Parents were encouraged to record all family goals on worksheets, to track their family's weekly progress, and to share their family experiences with the parent group at each subsequent intervention session. The C.H.A.M.P. Families program was offered at no cost to participants. Parking was free, and complimentary YMCA child minding and drop-in children's programming (i.e. an existing YMCA program called "Active and Creative Kids") was available for all children (including siblings) of parent participants. As mentioned previously, one C.H.A.M.P. Families 'booster session' was offered at 3 months post-intervention), and another, final session will be offered at 6-months post-intervention; these hands-on, activity-based sessions were developed to involve both parents and children, members of the research team, graduate students, health professionals and/or community organizations, and to include the provision of evidence-based resources and information, social support, and group-based discussions and activities related to child and family health and well-being in the home environment. Data were collected at four timepoints: baseline (≤ 4 weeks pre-intervention), mid-intervention (Week 6), post-intervention (≤2 weeks post- intervention), and at a 6-month follow-up (June 2018). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Feasibility of the pilot intervention using the RE-AIM Framework. |
| Key secondary outcome measure(s) |
As noted above, there were several secondary outcomes assessed in the C.H.A.M.P. Families research project, which represent the "Effectiveness" and "Maintenance-Individual" dimensions of RE-AIM discussed above. Data collection took place in the home of each participant to ensure the privacy and comfort of participants during the four measurement timepoints: baseline (≤4 weeks pre-intervention), mid-intervention (Week 6), post-intervention (≤2 weeks post intervention), and 6-month follow-up (June 2018). All of the secondary outcomes were assessed during each home visit, with the exception of the focus groups, which took place at the YMCA during the last group-based session of the intervention (Week 13). The following provides an overview of the secondary outcomes. |
| Completion date | 15/03/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 11 |
| Total final enrolment | 11 |
| Key inclusion criteria | 1. Parent of a child aged 6-14 years with BMI ≥85th percentile for age and sex (calculated using the CDC BMI Percentile Calculator for Child and Teens; https://nccd.cdc.gov/dnpabmi/Calculator.aspx) 2. At least one parent agreed to take part in the study 3. Both the child and his/her parent(s) were able to speak, read, and understand English |
| Key exclusion criteria | 1. Child did not have a BMI ≥85th percentile for age and sex 2. Parents and children did not provide consent and assent, respectively 3. Parents and children were unable to read, speak, or understand English 4. Child had a medical condition or used medication(s) that could limit study participation |
| Date of first enrolment | 01/05/2017 |
| Date of final enrolment | 11/09/2017 |
Locations
Countries of recruitment
- Canada
Study participating centre
London
N6A 3K7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results (participants’ perceptions) | 19/06/2019 | 07/11/2019 | Yes | No |
| Results article | 13/03/2023 | 15/03/2023 | Yes | No | |
| Protocol article | protocol | 14/12/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/03/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/11/2019: Publication reference added.
26/03/2019: Publication reference added.
26/04/2018: Participant information sheet information and IPD sharing statement have been added.