The children's health and activity modification program (C.H.A.M.P.): a community-based lifestyle program for children with obesity and their families
| ISRCTN | ISRCTN13143236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13143236 |
| Protocol serial number | GRT 2008-016 (The Lawson Foundation); Award ID: R4171A01 (The University of Western Ontario); ROLA #0000005584 (The University of Western Ontario); 161975 (Canadian Institutes of Health Research; Competition 2006-06CCT) |
| Sponsors | The University of Western Ontario, The Lawson Foundation |
| Funders | The Lawson Foundation, Canadian Institutes of Health Research |
- Submission date
- 17/03/2015
- Registration date
- 27/03/2015
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The increase of childhood obesity is a global public health concern. The Children’s Health and Activity Modification Program (C.H.A.M.P.), a 4-week camp-based program, was developed for children with obesity and their families using a multidisciplinary approach. The primary objective of the study was to test the reach, effectiveness, adoption, implementation and maintenance of the program. Secondary objectives were to improve: (a) physical activity behaviour among children both during and following the program; (b) physiological outcomes (e.g., standardized body mass index [z-BMI], body fat percentage, muscle percentage, fitness), and (c) psychological outcomes (e.g., task and barrier physical activity-related self-efficacy, health-related quality of life [QOL], etc.). Perceptions of the program from both children and caregivers were also assessed.
Who can participate?
Children aged between 8 and 14 years with a BMI greater than or equal to the 95th percentile for his/her age and gender. At least one caregiver from each family also participated in the family-based component of the study.
What does the study involve?
C.H.A.M.P. was a 4-week lifestyle intervention that was delivered to two groups of children and caregivers over the course of two years. All children attended the program on weekdays (i.e., Monday to Friday) from 9am-4pm for four consecutive weeks during the month of August, and caregivers attended weekly group-based educational sessions on four Saturdays from 10am-2pm. C.H.A.M.P. consisted of several group-based activities for the children including daily: (a) sport, fitness, strengthening, and/or games-based physical activity sessions; (b) behaviour modification counselling; and (c) dietary counselling. Weekly educational sessions for parents and caregivers targeted behaviour modification strategies, physical activity, and nutrition in the home environment among other topics. Post program group support was offered to both children and caregivers (combined) in the form of “booster sessions” held once every two months for one year following the program. Each family paid a fee of $200.00 (CAD) for participating.
What are the possible benefits and risks of participating?
Following completion of the study, a range of benefits were noted by and observed for children and caregivers as a result of participation in the program. These included a significant increase in physical activity, improvements in cardiovascular health, glucose metabolism and blood lipid levels, decrease in weight, increase in muscle and a general increase in quality of life. No-one suffered any adverse side effects to participating in the program. Before the study started, a number of potential risks for children were identified (and shared with families) including: physical discomfort and injuries associated with greater levels of physical activity; exposure to small amounts of radiation from the DXA scan used to assess body composition; varying degrees of discomfort and/or physical reactions (e.g., rashes) associated with some of the research-based assessments including vessel wall imaging, heart rate, and blood pressure measurements; and feelings of distress or discomfort due to discussions around body weight.
Where is the study run from?
C.H.A.M.P. took place at The University of Western Ontario in London, Ontario, Canada. However, various community settings (i.e., Canadian Centre for Activity and Aging, a local YMCA, and a nearby school field) were also used for specific activities.
When is the study starting and how long is it expected to run for?
January 2008 to September 2014
Who is funding the study?
The Lawson Foundation (Diabetes Funding Opportunity) in London, Ontario (Canada)
Who is the main contact?
Shauna Burke
sburke9@uwo.ca.
Contact information
Scientific
School of Health Studies
Western University
Arthur & Sonia Labatt Health Sciences Building
Room 337
London
N6A 5B9
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre single-cohort interventional feasibility study held over the course of two years |
| Secondary study design | Non randomised study |
| Scientific title | The Children's Health and Activity Modification Program (C.H.A.M.P.): a family-based lifestyle intervention for children with obesity and at risk for type II diabetes |
| Study acronym | C.H.A.M.P. |
| Study objectives | The purpose of the project was to develop, implement, and assess the effectiveness of a community- and group-based lifestyle intervention program for children with obesity and their families. A 4-week intervention (day-camp) was offered to two cohorts of children during the month of August in 2008 and 2009 and included physical activity, dietary, and behaviour modification components. Weekend educational sessions related to physical activity, dietary, and behaviour modification counseling were also held for caregivers, and follow-up support was offered to families in the form of 2-hour group-based “booster sessions” scheduled once every two months for one year following the formal intervention. The primary objective of the study was to assess the feasibility of C.H.A.M.P. using the RE-AIM framework; that is, to evaluate the reach, effectiveness, adoption, implementation and maintenance of the program. Secondary objectives were to improve and/or facilitate: 1. Physical activity behaviour among children both during and following the intervention; 2. Physiological outcomes (e.g., standardized body mass index [z-BMI], body fat percentage, muscle percentage, fitness), 3. Psychological outcomes (e.g., task and barrier physical activity-related self-efficacy, health-related quality of life [QOL], etc.). It was hypothesized that this 2-year pilot project would provide important information related to the preliminary effectiveness of the intervention in relation to a range of outcomes, as well as recruitment and logistical issues associated with the implementation of a research-based program for children with obesity. With regard to specific (secondary) outcomes, it was hypothesized that C.H.A.M.P. would be associated with improvements in children’s physical activity behaviours, as well as in the physiological and psychological outcomes of interest. |
| Ethics approval(s) | The University of Western Ontario Research Ethics Board for Health Sciences Research Involving Human Subjects (HSREB), 10/07/2008, ref: 15158 |
| Health condition(s) or problem(s) studied | C.H.A.M.P. was a community- and family-based lifestyle (feasibility) intervention that targeted children with obesity and their caregivers. |
| Intervention | C.H.A.M.P. was a feasibility study and we were interested in assessing various dimensions of the program (including its reach, efficacy/effectiveness, adoption, implementation, and maintenance). There was no control group; rather, children served as their own controls in that pre- and post-intervention assessments (as well as 3, 6, and 12 month follow-up assessments) were conducted to evaluate many of the variables of interest. Families were recruited through advertisements placed in the media (i.e., local newspapers, radio), posters displayed in the community (e.g., libraries, community centers, hospitals, and family medical clinics), physician referrals, and word-of-mouth. The length of recruitment was approximately 3 weeks (Year 1) and 3 months (Year 2) in duration. The following represents an overview of the program (treatment) components, as outlined (with the most detail) in our study protocol. CHILDREN’S COMPONENT Two cohorts of children attended camp for the month of August in 2008 (Year 1) and 2009 (Year 2) on weekdays from 9am until 4pm. During the 4-week program, children engaged in a variety of group-based physical and educational activities. Children usually completed one of each of the following sessions on a daily basis: education (e.g., related to physical activity, nutrition, anti-bullying, etc.), aerobic activity (e.g., dance, yoga, etc.), water-based activity (e.g., water polo, synchronized swimming, etc.), circuit-based or resistance training exercise (e.g., Thera-Band® exercise training, machine-based circuits, etc.), and games or sports (e.g., basketball, floor hockey, dodgeball, etc.). Physical activities, education sessions, and team building activities centered on a given ‘theme’ of the week; themes included Sports Week, Healthy Eating Week, Olympics Week, and Adventure Week. Thirty minutes was allocated for lunch each day, and food was not provided during the program. Guest speakers for the education and physical activity sessions for the children included the Principal Investigator, a Special Constable from the Campus Community Police, varsity and professional athletes and coaches, a Public Health Dietitian, and a Certified Co-Active Life Coach. The last day of each week consisted of an activity-based field trip (e.g., indoor rock climbing) and a movie, and a C.H.A.M.P. Talent Show took place on the last day of the 4-week intervention. The child-based portion of the intervention took place at the Canadian Centre for Activity and Aging in London, Ontario (Year 1), and at a local YMCA where children used the exercise equipment, swimming pool, gymnasium, and an interactive computer technology/exercise centre for children and youth (Years 1 and 2). FAMILY COMPONENT Parents and caregivers attended weekly group-based educational sessions on four consecutive Saturdays in August of 2008 (Year 1) and 2009 (Year 2) from 10am until 2pm. Sessions focused on nutrition education (e.g., an in-store supermarket tour and discussions related to portion sizes, label reading, and menu planning, delivered by a Registered Dietitian), healthy parenting (e.g., group discussions around effective parenting skills and issues such as self-esteem and coping with food-related issues, facilitated by a family therapist), diabetes education (e.g., a virtual anatomy “tour” of the human body and complications associated with diabetes, led by an exercise physiologist), anti-bullying (led by a parent support and advocacy organization that targets bullying in schools), family goal setting (e.g., a family goal setting workshop led by the Principal Investigator), and life coaching (e.g., discussions focused on the creation of a positive and self-esteem-enhancing family environment, led by a Certified Co-Active Life Coach). Although the children did not attend the family-based education sessions, parents and guardians were encouraged to bring their children (including siblings) to participate in supervised and structured physical activities led by the camp counsellors. Thirty minutes per group-based caregiver session were allotted for “family picnic time”, and a pot-luck lunch took place following the last session. All caregiver sessions took place at The University of Western Ontario, and parking was free for all participants. PROGRAM STAFF AND VOLUNTEERS Several camp counsellors (6 in Year 1, 10 in Year 2) and program volunteers (7 in Year 1, 9 in Year 2) were involved in the implementation of the intervention. All staff and volunteers were screened and completed a two-phased interview process; once hired, counselors were required to complete a police background check, CPR/First Aid training, and a one-week training program led by the Principal Investigator and Project Coordinator. All counselors were certified school teachers, university students, and/or employees at the program delivery settings (i.e., The University of Western Ontario, Canadian Centre for Activity and Aging, or the YMCA). Volunteers were university (graduate and undergraduate) students. PROGRAM COST The fee for the 4-week intervention (plus all post-program support sessions) was $200.00 (CDN). In addition to including all program activities, the fee contributed toward the cost of bussing from Monday to Friday and a one-month family membership at the YMCA. Parents were expected to provide lunches and snacks for their children because education related to the preparation of healthy meals (including lunches and snacks) was an important part of the program curriculum. FOLLOW-UP SUPPORT “C.H.A.M.P. Booster Sessions” were group-based support sessions held for participants (caregivers and children) at various locations (The University of Western Ontario, YMCA, other community-based facilities) once every two months for one year following the formal 4-week intervention. These follow-up sessions were designed to: 1. Provide an opportunity for the maintenance of social contact among children and family members following completion of the formal program 2. Re-iterate, emphasize, and provide new information and resources pertaining to behavior modification strategies, physical activity and healthy food choices. Sessions included activity-based (i.e., curling, dance, aerobic activity) classes, a healthy cooking demonstration with a public health dietitian, a follow-up session with a psychotherapist, and group discussions related to strategies for overcoming barriers to making healthy food choices and engaging in regular physical activity. The booster sessions also served as a means of disseminating research-based results related to the program and specific outcomes of interest. Additional means of follow-up support for families included bi-monthly C.H.A.M.P. newsletters in addition to telephone calls and e-mails. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
To answer our primary research question—that is, whether C.H.A.M.P. represented a feasible treatment option for children with obesity and their caregivers—data were collected in relation to the RE-AIM Framework, an evaluation tool for community-based health interventions. The following represents an overview of the RE-AIM dimensions, the methods used to measure each outcome in our study, and the time points at which each outcome was measured. |
| Key secondary outcome measure(s) |
Numerous variables of interest were considered to be secondary outcomes in the C.H.A.M.P. project. The following provides an overview of these outcomes, along with information about the method used to measure the outcome and the time points at which they were measured: |
| Completion date | 30/09/2014 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | Children were eligible to participate in the study if they: 1. Were male or female and between the ages of 8 and 14 years 2. Had a body mass index (BMI) > 95th percentile for age and gender 3. Had written clearance to engage in physical activity prior to beginning the program (eligible children underwent a general medical assessment conducted by a paediatrician at the Children's Hospital of Western Ontario) Caregivers were eligible to participate in the study if they had a child who met the above criteria. |
| Key exclusion criteria | Children were excluded from the study if they: 1. Were not between the ages of 8 and 14 2. Had a body mass index (BMI) that was not > 95th percentile for their age and gender 3. Possessed any contraindications for physical activity Caregivers were not eligible to participate in the study if their child was excluded for any of the above mentioned reasons. |
| Date of first enrolment | 11/07/2008 |
| Date of final enrolment | 31/07/2009 |
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 | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2012 | Yes | No | ||
| Results article | 17/12/2012 | Yes | No | ||
| Results article | 27/03/2015 | Yes | No | ||
| Results article | Burke, S. M., Shapiro, S., Petrella, R. J., Irwin, J. D., Jackman, M., Pearson, E. S., Prapavessis, H., & Shoemaker, J. K. Using the RE-AIM framework to evaluate a community-based summer camp for children with obesity: A prospective feasibility study. BMC Obesity. | 14/05/2015 | Yes | No | |
| Abstract results | 01/12/2011 | No | No | ||
| Other publications | 31/07/2009 | Yes | No |
Editorial Notes
17/12/2020: The total final enrolment was added.