Condition category
Not Applicable
Date applied
25/09/2017
Date assigned
04/10/2017
Last edited
04/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Yolanda Flores-Peña

ORCID ID

http://orcid.org/0000-0001-6200-6553

Contact details

Av. Gonzalitos 1500 Nte
Col. Mitras Centro
Monterrey
N. L.
Monterrey Nuevo León
64460
Mexico
+52 (0)81 811 6280 185
yolandaflores.uanl@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

I0002 - 247126

Study information

Scientific title

Intervention in maternal perception of pre-school child weight in Mexican and Mexican-American mothers: a pilot study

Acronym

HC / MPCW

Study hypothesis

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

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

Study design

Multicentre two-arm randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

Measured at baseline and 6 weeks:
1. Maternal feeding styles, assessed using the Caregiver Feeding Style Questionnaire that categorizes the participants in four styles: a) authoritative, b) authoritarian, c) indulgent, and d) uninvolved
2. Maternal perception of influence on her child's health behaviors, assessed using two questions of the Questionnaire Perceptions about Physical Appearance and Health: I can influence my child's food choices and I can influence my child's amount physical activity. Participant with agreement or strong agreement were considered to have self-efficacy for the health behavior. Those with agreement or strong agreement to both statements were considered as affirming high self-efficacy for influencing their child’s health behaviors (Eckstein et al., 2006).
3. Obesogenic environment evaluated by the Family and Nutrition and Physical Activity (FNPA) screening tool. The FNPA is a behaviorally based assessment designed to allow parents to evaluate obesogenic environments and practices that may predispose youth to becoming overweight.
4. Child BMI and percentage body fat. The child’s weight will be measured by Seca Scale 813 and height by Seca stadimeter 214, the body fat percentage will be measured by bioelectrical impedance by InBody 230. Child BMI will be classified according to the percentile in malnutrition (percentile <3), low weight (≥3 and <15), normal weight (≥15 and < 85), SP (≥85 but < 97) and OB (≥97) (WHO, 2012).

Overall trial start date

01/02/2017

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

360 mother-child pairs (90 pairs per center)

Participant exclusion criteria

1. Mothers who plan to change address
2. Children with special motor limitation or any disease that limits their growth and development

Recruitment start date

01/03/2017

Recruitment end date

30/03/2018

Locations

Countries of recruitment

Mexico, United States of America

Trial participating centre

Jardín de Niños Juan Escutia
Monterrey
64379
Mexico

Trial participating centre

Jardín de Niños Estefanía Castañeda
Monterrey
64330
Mexico

Trial participating centre

Jardín de Niños Melchor Muzquiz
66440
Mexico

Trial participating centre

Jardín de Niños Estefanía Castañeda
H. Matamoros
87370
Mexico

Trial participating centre

Jardín de Niños Rita Padrón
H. Matamoros
87430
Mexico

Trial participating centre

Club 20-30
H. Matamoros
87450
Mexico

Trial participating centre

Jardín de Niños Esperanza Tobias Ruiz
H. Matamoros
87380

Trial participating centre

Kindergarten Víctor Manuel García Ortega
Guadalupe, Zacatecas
98615
Mexico

Trial participating centre

Kindergarten María Guadalupe Vega de Luevano
Zacatecas, Zacatecas
98040
Mexico

Trial participating centre

Rhapsody Head Start Center 78216
San Antonio, Texas
78216
United States of America

Trial participating centre

Pilgrim Head Start Center 78213
San Antonio, Texas
78213
United States of America

Trial participating centre

Lackland Head Start Center 78227
San Antonio, Texas
78227
United States of America

Sponsor information

Organisation

Universidad Autónoma de Nuevo León

Sponsor details

Ave. Barragán S/N
Ciudad Universitaria
San Nicolás de los Garza
Nuevo León
66220
Mexico
+52 (0)81 83 29 40 32
d.investigacion@uanl.mx

Sponsor type

University/education

Website

http://investigacion.uanl.mx/contacto-2/

Funders

Funder type

Government

Funder name

The National Council for Science and Technology (Mexico)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Kellogg's Nutrition & Health Institute (Mexico)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be published in peer-reviewed journals and communicated to key audiences, including personnel of participant centres:
1. The protocol will be published immediately after registration
2. The results from the Mexican States will be published in February 2018
3. Other publications after these dates

IPD sharing statement
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.

Intention to publish date

01/02/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes