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ObesityNCT04374292

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

A study testing Family intervention and Usual nutritional consultation in people with Obesity and Child Obesity, run by Hospital Infantil de Mexico Federico Gomez.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 11 years
Conditions the study is for
Obesity, Child Obesity
What is being tested?
Family intervention and Usual nutritional consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
No sites listed yet
Study dates
5 Jan 2011to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Open Clinical Trial to Modify the Eating Habits of Children With Obesity, Comparing the Nutritional Family Intervention Versus the Usual Consultation

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:

Read more
  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. 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.

Randomized clinical trial, 177 mother/obese child pairs participated, 90 in the intervention group (IG) and 87 in the control group (CG). The intervention group attended six group education sessions to promote healthy eating and 87 received the usual nutritional consultation, over a three-month period. Frequency of food consumption, behaviors during feeding in the house and metabolic profile was evaluated. Data was compared using Student's t or X2.

Read the detailed description

The aim of this study is evaluate the change in eating behaviors, metabolic condition, and nutritional status measured by anthropometry, in children with obesity who were prescribed a diet to reduce their body weight in the usual nutritional consultation, in comparison to children whose mothers participated in an intervention of six group sessions to acquire healthy dietary habits.

Methods. Design. The Obesity Clinic at Federico Gómez Children's Hospital of Mexico conducted a randomized clinical trial between January 2011 and December 2014 with approval from the hospital's Research, Ethics and Biosecurity Committee. 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.

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. Children in this group were not prescribed diets to reduce their body weight. 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. Neither group of children received physical activity programs. 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.

The assignment to intervention or control groups was made using a block randomization with 8 mother/child pairs in each block to assure equal allocation to groups. One of coworkers not involved in data collection produced a computer-generated randomization list using the Stata 11.0 program. Children were randomized at the end of the baseline examination. Taking experiences from the published studies the sample size calculation was based on to expect differences of at less 20% in eating habits between the mothers/children dyad of the intervention or control groups, to detect differences with significant level of 5% and 80% power; the size of sample required was 72 mother/children pairs per group and to allow for 20% drop-out during the follow-up, the investigators aimed at recruiting 86 mother/children dyad per group.

Measurements at the beginning and end of the study. Anthropometry. The weight, height and waist circumference of children in both groups were measured according to international procedures. Weight was measured on a mechanical scale (Seca model-700, SECA Corp., Hamburg, Germany) with 50 g precision. Height was measured on a stadiometer (SECA model-225, SECA Corp., Hamburg, Germany) 0.1 cm precision. Meanwhile, waist circumference was measured at the end of an exhalation with non-elastic flexible tape (Seca model-200, SECA Corp., Hamburg, Germany) in a standing position at the midpoint between the lower costal border and the iliac crest. Body Mass Index (BMI) and percentile value were calculated using CDC data for reference, children with a BMI ≥ 95 pc were categorized with obesity.

Blood pressure. Blood pressure was measured on children's right arm with a mercury sphygmomanometer (ALPK2, Tokyo, Japan) using a cuff that suited arm length and perimeter and following 2004 National High Blood Pressure Education Program guidelines.

Questionnaires. A questionnaire of socio demographic data was applied to the mothers at baseline. In addition, a survey of family feeding habits at home at baseline and three months was applied, the mother was asked about the child's breakfast habit and bring lunch to consume at school, family feeding habits at the time of sitting at the table (place the salt shaker, sugar and sweetened soft drinks on the table, fill the plate, repeat saucer, force the child to finish the meal, accept the exchange of food to what the child wants), frequency of consumption of food (fried, roasted, fruits and vegetables) and drinks (simple water, sugary drinks prepared at home, natural juice, industrialized juice and soft drinks). The amounts of food consumption were not evaluated. A survey of physical activity and sedentary activities was applied; no physical activity intervention was performed during this study.

Blood sample. 5 mL venous blood samples after 12 h fasting periods were drawn to determine glucose (mg/dL)(hexokinase method Dimension RxL Max, Siemens Euro, DPC, Llanberis, UK), insulin (mIU/mL) (chemiluminescence IMMULITE 1000, Siemens), HDL cholesterol (mg/dl) (enzymatic reaction/catalase, using ADVIA ® 1800 equipment), and triglycerides (mg/dl) (ILAB 300, Instrumentation Laboratory, Barcelona Spain). Participating children's HOMA-IR index was obtained through glucose and insulin data (If xGf/22.5).

Statistical analysis. Central tendency measures were used to describe the study population's baseline characteristics. Student's t-test for independent samples was used to compare continuous variables, such as socio-demographic data, dietary habits, feeding behaviors, and biochemical and anthropometric data. Pearson X2 test was used to compare proportions between groups. Continuous data without normal distribution was managed using logarithmic transformation or square root. Student's t-test for related samples was used to identify differences before and after the intervention in each group or its non-parametric Wilcoxon equivalent. The equal proportions test was used to assess the difference in proportions in dietary habits and behaviors between groups. Statistical significance was considered at P < 0.05. Analyses were carried out with STATA SE v.12.0 (Stata Corp, CollegeStation, TX, USA).

Being tested
Family intervention, Usual nutritional consultation
Keywords
Feeding behavior, Intervention, Insulin resistance, Dietary habits, Childhood obesity
Medical subject headings
Obesity, Pediatric Obesity, Feeding Behavior, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family interventionBehavioural

    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
  • Usual nutritional consultationOther

    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.

Study groups in NCT04374292
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention 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.
Receives: Behavioral: Family intervention
Control groupActive comparatorControl 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.
Receives: Other: Usual nutritional consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HOMA-IR

    Change in Homeostasis Model to Assess the Insulin Resistance Index

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

  2. 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

    Measured: It was measure at baseline and three months

Secondary outcomes (1)
  1. Change in BMI percentile

    Change in Body mass index percentile

    Measured: It was measure at baseline and three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start5 Jan 2011
  3. Primary completion12 Jul 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04374292
Sponsor's protocol ID
HIM 2011-003
Status last verified
Mar 2020
First submitted
19 Apr 2020
Last updated
7 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results obtained from the study will be analyzed and published in an international indexed journal.

Publications

  • 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.

    PubMed 27342650
  • 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.

    PubMed 32795294

Questions about this trial

What is this clinical trial studying?

A study testing Family intervention and Usual nutritional consultation in people with Obesity and Child Obesity, run by Hospital Infantil de Mexico Federico Gomez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HOMA-IR (time frame: It was determined at the beginning of the study and at the end of the intervention (0 and 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04374292, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.

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