Healthy Change: intervention in maternal perception of pre-school child weight
| ISRCTN | ISRCTN12281648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12281648 |
| Protocol serial number | I0002 - 247126 |
| Sponsor | Universidad Autónoma de Nuevo León |
| Funders | The National Council for Science and Technology (Mexico), The Kellogg's Nutrition & Health Institute (Mexico) |
- Submission date
- 25/09/2017
- Registration date
- 04/10/2017
- Last edited
- 06/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Childhood obesity is a public concern for its effects on health. Mothers might not participate in activities to prevent and treat obesity unless they accurately perceive their child’s weight. Studies conducted in different countries indicate that mothers do not accurately perceive their child’s weight, which is more remarkable when the child is overweight/obese. Most interventions targeting childhood obesity do not test the mother’s perception of her child’s weight. The aim of this study is to test the feasibility and effect of the "Healthy Change" intervention on mothers’ perception of the weight of their pre-school child.
Who can participate?
Mothers of children aged 3 to 5
What does the study involve?
Mothers and children are randomly allocated to either the intervention group or the control group. The mothers in the intervention group attend four weekly group education sessions about obesity, healthy eating and physical activity. The mothers in the control group attend four weekly group education sessions about hygiene. The children’s height, weight and body fat percentage are measured at the start of the study and 6 weeks later, while the mothers answer questionnaires and focus groups are conducted.
What are the possible benefits and risks of participating?
Potential benefits include increased awareness of overweight and obesity in preschoolers and improved knowledge and skills of raising healthy weight children. This study will shed light on developing effective primary obesity prevention strategies for Hispanic mothers in Mexico and USA. This study has no foreseeable risks, discomforts or hazards.
Where is the study run from?
Three centres in three Mexican States (Nuevo Leon, Tamaulipas and Zacatecas), and one centre in San Antonio, Texas (USA)
When is the study starting and how long is it expected to run for?
February 2017 to November 2018
Who is funding the study?
1. The National Council for Science and Technology (Mexico)
2. The Kellogg's Nutrition & Health Institute (Mexico)
Who is the main contact?
Dr Yolanda Flores-Peña
yolandaflores.uanl@gmail.com
Contact information
Public
Av. Gonzalitos 1500 Nte
Col. Mitras Centro
Monterrey, N. L.
Monterrey Nuevo León
64460
Mexico
 ORCID ID |
0000-0001-6200-6553 |
|---|---|
| Phone | +52 (0)81 811 6280 185 |
| yolandaflores.uanl@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre two-arm randomized trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Intervention in maternal perception of pre-school child weight in Mexican and Mexican-American mothers: a pilot study |
| Study acronym | HC / MPCW |
| Study objectives | 1. Mothers of the HC intervention group will accurately perceive body weight of her child at the end of the intervention 2. Core elements of the HC intervention (maternal feeding styles, self-efficacy, and family nutrition and physical activity) show changes that represent positive scores 3. Reduce or maintain child's body mass index (BMI) and body fat percentage (BFP) |
| Ethics approval(s) | 1. University Autonomus of Nuevo Leon / College of Nursing, 02/06/2015, ref: FAEN-P-1144 2. University of Texas at San Antonio, 31/01/2017, ref: 16-203N |
| Health condition(s) or problem(s) studied | Maternal perception of her child's body weight |
| Intervention | The Healthy Change intervention is a multicentre two-arm randomized trial with four centres, three in Mexico: Nuevo León, Tamaulipas and and Zacatecas, and one in USA, San Antonio, Texas. Each center will have an intervention and a control group. A total of 360 mother-child pairs (90 pairs per center) will be randomly and evenly allocated to either the intervention or control group. Participating mothers in the intervention group will attend four weekly group education sessions related to Healthy Growth, covering the following contents: 1) Understanding excess weight and obesity as a health problem and their current and future health consequences; 2) How is my child’s weight? 3) Maternal feeding practices and physical activity, 4) I can do, which includes strategies for management child lifestyle behaviors related to the child’s weight. The mothers in the control group will attend four weekly group education sessions related to Hygiene and Health Promotion, covering the following topics: 1) The mother as her child’s hygiene promoter; 2) Hygiene and food safety at home; 3) Safe ways to store food in your kitchen; and 4) Accident prevention at home and surrounding areas. First week: basal measurements Four weeks: intervention Sixth week: final measurements |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Maternal perception of child weight (MPCW), measured using the questionnaire Perceptions about Physical Appearance and Health, using the question: I feel my child is: underweight, a little underweight, about the right weight, a little overweight, overweight, and body sketches in the age range 2 to 5 years old. Measured at baseline and 6 weeks. |
| Key secondary outcome measure(s) |
Measured at baseline and 6 weeks: |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 360 |
| Key inclusion criteria | 1. Women who are identified as mother of a child aged between 3 to 5 years 2. Child enrolled in one of the institutions selected in Mexico’s States 3. Mothers selected from the population that attends the Head Star Center located in San Antonio, Texas, who are Mexican-American |
| Key exclusion criteria | 1. Mothers who plan to change address 2. Children with special motor limitation or any disease that limits their growth and development |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 30/03/2018 |
Locations
Countries of recruitment
- Mexico
- United States of America
Study participating centres
64379
Mexico
64330
Mexico
Mexico
87370
Mexico
87430
Mexico
87450
Mexico
87380
Mexico
98615
Mexico
98040
Mexico
78216
United States of America
78213
United States of America
78227
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | All data will be stored in a secured laboratory or office facility with access limited to research staff only. All hard copy files will be stored in locked filing cabinets within the laboratory or office and all electronic files will be stored on password protected computers. Only the research staff will have access to files and the link connecting names to the issued identity codes. All the staff will undergo rigorous training on data collection, data entry, and data storage procedures to ensure all participant information is protected. Research records will not be released without an individual’s consent unless required by law or a court order. Records may be viewed by the Institutional Review Board (IRB) of College of Nursing of The University Autonomus of Nuevo Leon and the IRB of The University of Texas at San Antonio, but the confidentiality of all records will be protected to the extent permitted by law. The data resulting from participants may be used in publications and/or presentations but participants’ identities will not be disclosed. To help the trialists to remember the information discussed in the focus group, the discussion session will be audio-taped. Audiotapes will be transcribed by a trained research staff. Transcriptions will be used for analysis. All storage of data will take place on password protected computers that only research staff have access to. No information identifying individuals or any institution will be reported. Participant identity, comments, as well as all audiotapes and written records will be kept confidential and secure. All data collected from these focus groups will have names removed upon collection, such that names will not be used at any time during the research process, or the publication of findings. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/05/2018 | 01/07/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2019: The intention to publish date was changed from 01/02/2018 to 01/12/2019.
01/07/2019: Publication reference added.
