Dietary Habits and Metabolic Response in Obese Children Whose Mothers Received an Intervention to Promote Healthy Eating

NCT04374292 | Completed DMC

• 1 other identifier: HIM 2011-003
• Study Type: interventional
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief Summary

Unhealthy eating habits inside and outside the home lead to developing obesity, leading to clinical and metabolic disorders, such as insulin resistance, metabolic syndrome, and chronic degenerative diseases, which are the leading causes of death in adult life. The present study compared changes in dietary habits, behaviors and metabolic profiles of obese children whose mothers attended group sessions, with those who received the usual nutritional consultation. The hypotheses were:

1. 1.The mother's training in healthy eating methods, eliminating foods and nutrients that represent metabolic and cardiovascular risk, will change the consumption of these foods in the family, reducing them by 20% and increasing the consumption of food in the same proportion. beneficial, compared to the family of the child who only receives individual consultation.
2. 2.Children with obesity who modify or eliminate metabolic and cardiovascular risk foods and nutrients from their normal diet will have a weight loss of -1.5 BMI compared to children who only receive the usual consultation.

Conditions

Obesity; Child Obesity

Keywords

Feeding behavior; Intervention; Insulin resistance; Dietary habits; Childhood obesity

Outcome Measures

Primary Outcomes (2)

• Change in HOMA-IR

  Change in Homeostasis Model to Assess the Insulin Resistance Index

  It was determined at the beginning of the study and at the end of the intervention (0 and 3 months)

• Relative percentage obtained from the change in eating habits at the start of the study at 3 months.

  Changes in eating habits at home were obtained using the relative percentage. The change was obtained by comparing the initial percentage of each habit (100%) (baseline) versus the final percentage of the eating habit (3 months). Feeding habits are: * Breakfast * Habits at lunchtime: Putting salt on the table, putting sugar on the table, putting sweet soft drinks on the table, serves the right portion filling the food plate, repeating portion, forcing to finish food, accepting food substitutions, * Frequency of food consumption: fried foods (\> 3times/wk), roasted foods, fruits, vegetables, frequency of beverage, simple water, sweetened water prepared at home, natural juice, industrialized juice, soft drinks * Time to finish food * Children watching TV at mealtime

  It was measure at baseline and three months

Secondary Outcomes (1)

• Change in BMI percentile

  It was measure at baseline and three months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group mothers (n = 90) attended six weekly group sessions, which were led by nutritionists and lasted 90 minutes. The key message was that healthy dietary habits and health risks are acquired at home and that opportunities for change can be identified in the processes that surround meal times. It begins with selecting and purchasing food, followed by preparation and consumption behaviors. Mothers were encouraged to participate in the sessions which involved the use of food models, videos, slides, and, in some cases, real food. Upon completing each session, mothers were given printed material to add to a home consultation manual. Upon concluding consultations and group sessions, mother/child pairs from both groups were asked to return for monthly follow-ups over the next three months.

Behavioral: Family intervention

Control group

ACTIVE COMPARATOR

Control group mothers and children (n = 87) were given the usual nutritional consultation and were prescribed diets that covered their energy requirements according to their age and sex. Similarly, CG mother/child pairs received information regarding food groups and portion sizes, were trained in the use of the food equivalence system to encourage variation, and were instructed on how to prepare the diet at home.

Other: Usual nutritional consultation

Interventions

Family intervention BEHAVIORAL

Topics covered in each session with intervention group mothers. 1. Dietary and physical activity habits and their link to obesity and cardio-metabolic diseases. Children learn about healthy eating habits and health risks at home. 2. Food-preparation processes. Selecting and purchasing food and beverages; importance of food groups and their impact on health; importance of fruit and vegetables. Balance between food groups, source of foods, organic or industrialized. Family menu preparation. 3. Habits and behaviors surrounding eating processes identified as health or risk factors, such as energy density, portion-size control, controlling emotional eating. 4. Beverages. Water versus sugar-sweetened drinks prepared at home or purchased at the store. 5. Preventing the risk of cardiovascular diseases by learning healthy eating habits and practicing these habits at home. 6. Integration. Practicing the skills learned during the intervention in each stage of preparing food and eating

Intervention group

Usual nutritional consultation OTHER

Control group mothers and children (n = 87) were given the usual nutritional consultation and were prescribed diets that covered their energy requirements according to their age and sex. CG mother/child pairs received information regarding food groups and portion sizes, were trained in the use of the food equivalence system to encourage variation, and were instructed on how to prepare the diet at home.

Control group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and their families who come to the obesity clinic of the Federico Gómez Children's Hospital in Mexico who live in Mexico City or in the metropolitan area.
• Aged 5 to 11 years, both sexes.
• Children who can attend a consultation on a monthly basis for 3 months.
• Children and parents who have given their informed consent and assent in writing.

You may not qualify if:

• Children with obesity who receive medications that alter their body composition such as steroids, antiretrovirals and appetite stimulants.
• Children who are already under nutritional, medical or pharmacological treatment for their obesity.
• Children with syndromes whose body composition is altered, such as Cushing and other genetics.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Related Publications (2)

• Vilchis-Gil J, Klunder-Klunder M, Duque X, Flores-Huerta S. Decreased Body Mass Index in Schoolchildren After Yearlong Information Sessions With Parents Reinforced With Web and Mobile Phone Resources: Community Trial. J Med Internet Res. 2016 Jun 24;18(6):e174. doi: 10.2196/jmir.5584.

  PMID: 27342650 BACKGROUND

• Lopez-Contreras IN, Vilchis-Gil J, Klunder-Klunder M, Villalpando-Carrion S, Flores-Huerta S. Dietary habits and metabolic response improve in obese children whose mothers received an intervention to promote healthy eating: randomized clinical trial. BMC Public Health. 2020 Aug 14;20(1):1240. doi: 10.1186/s12889-020-09339-4.

  PMID: 32795294 DERIVED

Related Links

• PDF of paper

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Feeding Behavior; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Iris Nayeli López-Contreras, MSc

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After providing written consent, 177 children with obesity (BMI ≥ 95 pc) of age 5-11 years and their mothers were randomly assigned to participate in the intervention group (IG) or the control group (CG).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After providing written consent, 177 children with obesity (BMI ≥ 95 pc) of age 5-11 years and their mothers were randomly assigned to participate in the intervention group (IG) or the control group (CG). None of the participating children were receiving pharmacological treatment for obesity, were morbidly obese or were associated with a genetic syndrome. Intervention group mothers (n = 90) attended six weekly group sessions, which were led by nutritionists and lasted 90 minutes.

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: May 5, 2020
• Study Start: January 5, 2011
• Primary Completion: July 12, 2013
• Study Completion: November 1, 2013
• Last Updated: May 7, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The results of the study will be published in an international indexed journal, approximately in July 2020.
• Access Criteria: The results will be available to the public and the scientific community from the publication of the article.