Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Effectiveness of a Family Playful Ludic Educational Strategy Reinforced With the Use of Information and Communication Technologies in the Prevention and Reduction of Childhood Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this non-randomized clinical controlled trial is to evaluate the impact of a playful family education strategy reinforced by the use of communication technologies in childhood obesity The main questions to answer are
Does a technogical reinforced ludical family strategy might reduce overweight and childhood obesity prevalence and incidence reduction
Can digital reinforcement might decrease body weight BMI body fat mass and waist circumference in overweight or obese children
Does dietary habits might be improved by a technologically reinforced playful family workshop
Researchers will compare an obesity childhood digital reinforced group to an overweight control overweight group an overweight workshop group and a childhood obesity control group to see if technological reinforcement works to reduce and prevent childhood obesity
Does a technogical reinforced ludical family strategy might reduce overweight and childhood obesity prevalence and incidence reduction
Can digital reinforcement might decrease body weight BMI body fat mass and waist circumference in overweight or obese children
Does dietary habits might be improved by a technologically reinforced playful family workshop
Researchers will compare an obesity childhood digital reinforced group to an overweight control overweight group an overweight workshop group and a childhood obesity control group to see if technological reinforcement works to reduce and prevent childhood obesity
Detailed Description:
One of the main worldwide health problems is adult and childhood obesity due to the complications arising from this As World Obesity Federation WOF reported that in 2020 a total of 139 billion of adults were overweight and 081 billions were obese while 260 million of children were overweight and 175 millions had obesity Additionally in 2022 according to the Encuesta Nacional de Salud y Nutrición ENSANUT 2020-2022 an 192 of childhood overweight prevalence was reported and 181 of childhood obesity which places our country as the second place in childhood obesity worldwide only preceded by the USA
Although it is well-known that the main etiological factor are the poor eating habits promoted by the excessive consumption of sweetened beverages and ultra-processed foods Additionally to the nutritional educational programs and guidelines some strategies have been proposed in Mexico in an attempt to reduce its consumption such as the tax to soft drinks and junk food and the front labeling of foods
However previous studies have demonstrated that a family program with the participation of children and parents is required but not only by the implementation of integrative workshops but through the reinforcement and support with the use of current technologies that have confirmed an improvement in learning processes
So in a pursuit of lowering childhood obesity and overweight prevalence and incidence researchers created a non-randomized multicentric clinical trial to assess the efficacy of a technologically reinforced playful family educational workshop on the treatment and prevention of this public health problem
For this a total of 196 participants will be allocated into four interventional groups
1 Overweight children control group n 49 children BMI above the 85th percentile under conventional medical treatment over six months and a 18 months post-interventional follow-up
2 Overweight children workshop group n 49 children BMI above the 85th percentile under conventional medical treatment plus a playful ludical family educational workshop over six months and a 18 months post-interventional follow-up
3 Childhood obesity control group n 49 children BMI above the 97th percentile under conventional medical treatment over six months and a 18 months post-interventional follow-up
4 Childhood obesity digitally reinforcement group n 49 children BMI above the 97th percentile under conventional medical treatment plus a playful ludical family educational workshop and technological reinforcement over six months and a 18 months post-interventional follow-up
The main objective is that the overweight children workshop group achieve a normal weight or maintain in an overweight status and those with childhood obesity and digital reinforcement become overweight or reduce body weight fat mass and waist circumference as secondary objectives
Nevertheless researchers expect the improvement of dietary habits assessed by the 24-hour Food Frequency Questionnaire FFQ in both interventional groups that is the overweight workshop group and the childhood obesity digitally reinforced group
Although it is well-known that the main etiological factor are the poor eating habits promoted by the excessive consumption of sweetened beverages and ultra-processed foods Additionally to the nutritional educational programs and guidelines some strategies have been proposed in Mexico in an attempt to reduce its consumption such as the tax to soft drinks and junk food and the front labeling of foods
However previous studies have demonstrated that a family program with the participation of children and parents is required but not only by the implementation of integrative workshops but through the reinforcement and support with the use of current technologies that have confirmed an improvement in learning processes
So in a pursuit of lowering childhood obesity and overweight prevalence and incidence researchers created a non-randomized multicentric clinical trial to assess the efficacy of a technologically reinforced playful family educational workshop on the treatment and prevention of this public health problem
For this a total of 196 participants will be allocated into four interventional groups
1 Overweight children control group n 49 children BMI above the 85th percentile under conventional medical treatment over six months and a 18 months post-interventional follow-up
2 Overweight children workshop group n 49 children BMI above the 85th percentile under conventional medical treatment plus a playful ludical family educational workshop over six months and a 18 months post-interventional follow-up
3 Childhood obesity control group n 49 children BMI above the 97th percentile under conventional medical treatment over six months and a 18 months post-interventional follow-up
4 Childhood obesity digitally reinforcement group n 49 children BMI above the 97th percentile under conventional medical treatment plus a playful ludical family educational workshop and technological reinforcement over six months and a 18 months post-interventional follow-up
The main objective is that the overweight children workshop group achieve a normal weight or maintain in an overweight status and those with childhood obesity and digital reinforcement become overweight or reduce body weight fat mass and waist circumference as secondary objectives
Nevertheless researchers expect the improvement of dietary habits assessed by the 24-hour Food Frequency Questionnaire FFQ in both interventional groups that is the overweight workshop group and the childhood obesity digitally reinforced group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0594 | OTHER_GRANT | None | None |
| 09-CEI-009-20160601 | OTHER | None | None |
| 17 CI 09 015 006 | OTHER | None | None |