Prevention Childhood ObesityNCT06617299

Cognitive-behavioral Intervention to Increase the Practice of Responsive Feeding and Maintain Healthy Weight in Infants

A study testing Intervention Identifies and Responds in people with Prevention Childhood Obesity, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Prevention Childhood Obesity
What is being tested?: Intervention Identifies and Responds
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteMexico
Study dates: 10 Sep 2024to 25 Feb 2025
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Mother/child dyad, apparently healthy.
Minimum of 12 hours postpartum and/or cesarean section.
Mother who knows how to read and write.
Mother who has a smartphone.
Mother with internet access.
Mother who agrees to participate in the study.

Who cannot join

Hospital stay of the mother/child dyad for more than 7 days after birth.
Child-related exclusions:
Gestational age under 37 weeks (SDG).
Presence of a congenital anomaly.
Physical disability that could affect feeding (e.g., cleft palate, cleft lip).
Low birth weight (< 2,500 g).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: Cognitive-Behavioral Intervention Targeting Mothers to Increase Practice of Responsive Feeding and Maintain Healthy Weight in Infants Minors

Introduction: Childhood overweight and obesity in Mexico is a serious public health problem. Perceptive eating is a factor in the prevention of obesity and occurs when the caregiver recognizes the signs of hunger and satiety, responds in a timely manner to these needs. However, its implementation is often a challenge for parents. Studies show that there is low knowledge and self-efficacy, as well as erroneous beliefs about food. Teaching perceptive eating can lead to: the development of healthy eating habits, generate warm environments in which the interaction between parents and children is strengthened and promote self-regulation of hunger and satiety sensations and prevent overweight and obesity. Interventions on Responsive Feeding for the prevention of healthy weight in infants under six months of age are null in Mexico. Objective: To evaluate the effect of the intervention: \"Identify and Respond\" aimed at Mexican mothers to increase the practice of Responsive Feeding and maintain a healthy weight in children under 6 months of age. Methodology: The present study will be a pilot clinical trial type intervention study because the preliminary effect will be evaluated where the Experimental Group will receive the intervention aimed at increasing the practice of Responsive Feeding , there will be randomization of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later). The sample consisted of 72 mothers with children younger than 6 months for each group (N=144).

Conditions: Prevention Childhood Obesity
Being tested: Intervention Identifies and Responds
Keywords: Infants, Responsive Feeding

What participants receive

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

Intervention Identifies and RespondsBehavioural
The treatment of Experimental Group is described, which is made up of eight individual sessions taught over three months. Session one will be in face-to-face format, the content, resources and activities are described in tables 2 and 3. The remaining seven sessions will be follow-up sessions (four sessions by message (WhatsApp®) where motivational messages and reinforcement information will be sent; and 3 sessions by phone call for feedback, see details of time, content, activities and resources in tables 2 and 3.
The design of the intervention is aimed at increasing the practice of Responsive Feeding in mothers with children under 6 months of age, is based on the methodology of Sidani and Braden (2021); on CHW (Bandura, 1986); and behavior change techniques to help people have healthy eating habits (Michie et al., 2011).

Study groups in NCT06617299
Study group	Role	What they receive
Responsive Feeding Group	Experimental	Group to receive information on responsive feeding Receives: Behavioral: Intervention Identifies and Responds
Breastfeeding Group	No intervention	Group to receive information disseminated by hospital staff on breastfeeding

What is being measured

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

Change the practice of responsive feeding in mothers with infants under 6 months of age.
To measure the practice of Responsive Feeding in the mother/child dyad, the Feeding Practices and Structure Questionnaire (FPSQ) will be used, a questionnaire in original English designed by Jansen et al., (2022), replicated in the Mexican context (Pérez, 2023). It aims to measure the responsiveness of parents in children under 6 months, mainly breastfed or bottle-fed throughout childhood. It is made up of 18 items divided into 4 dimensions: 1) on-demand feeding, which refers to the fact that the parents make the decision about when the child should be fed; 2) use of food to calm conceptualized as the fact that parents use food to calm or control emotions; 3) persuasive feeding is the fact that parents encourage (pressure) the child to eat more, even when they show signs of satiety; and 4) parent-directed feeding referring to the fact that the parents make the decision (or have a rule) about how long / how much the child feeds.
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Healthy weight maintenance in infants
The nutritional status of the infant will be analyzed through the indicators of weight/length and BMI/age during birth and follow-up measurements, this according to the WHO and the open-access computer program Anthro®, the patterns of child growth in children under two years of age classified by the z-scores will be used : malnutrition (≤ -2 SD); normal (≥ -1 and ≤ 1 SD); SP (\> 1 and ≤ 2 DE) and OB (≥ 2 DE).
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

Secondary outcomes (5)

Mother's Knowledge on the development and feeding practices of the child
To measure the knowledge variable about Responsive Feeding, it will be measured with the Infant Hunger and Satiety Signals Knowledge Scale, originally a scale used in the United States, it was adapted by Ortiz et al. (2020) to the Mexican context, it aims to measure the mother\'s knowledge regarding the hunger and satiety signals emitted by the infant under 6 months of age. It is structured by 2 questions: 1) Do you know that your child is hungry? with 10 signs to identify them; 2) Do you know that your child is full or full? followed by 8 satiety signals to identify them.
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Maternal attitudes Mother's disposition towards infant feeding methods
To measure attitudes towards feeding, the Iowa Infant Feeding Attitude Scale (De la Mora et al., 1999) adapted to the Mexican context by Aguilar-Navarro et al. (2016) will be used, it is a one-dimensional scale made up of 17 items that measure the attitude of mothers towards infant feeding (breastfeeding and/or formula feeding). The way to respond is through a five-point Likert-type scale, where 1) totally disagree; 2) disagree; 3) neither disagree nor agree; 4) agree; 5) Totally agree. It is interpreted that the lower the score, the breastfeeding method is favored and the higher the score, the better attitudes towards formula feeding.
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Infant temperament
To measure infant temperament, the Infant Behavior Questionnaire (IBQ-R) (Putnam, 2014) will be used, adapted to the Mexican context by Ortega et al. (2012), its main objective is to measure infant temperament during the last week prior to its application. It is structured by 37 items divided into three dimensions: 1) extroversion; 2) negative affectivity; and 3) self-regulation.
It has a 7-point Likert-type response scale ranging from 1 = never to 7 = always, for interpretation item 11 evaluates inversely, a sum of the total of the items is made and it is considered that, the higher the score, the greater the characteristic of child temperament according to the three dimensions of the questionnaire.
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Parental Self-Efficacy
To measure parental self-efficacy , the Karitane Parental Trust Scale (KPCS) proposed by Crncec et al. (2008) will be used, which aims to measure parental self-efficacy in parents of infants aged 0 to 12 months. It is made up of 15 items divided into three dimensions: 1) perceptions of parenting capacity (5, 4, 6, 2, 8, 7, 3 and 11); 2) available parenting support (15, 13, 9, 14, and 12) and 3) perceptions of child development (10 and 1).
The structure to answer each of the questions is through a Likert-type scale, where 4 possible options are presented: 0=No, almost never, 1= No, not very often, 2= Yes, sometimes, 3= Yes, most of the time. Despite having dimensions, the authors recommend that its evaluation be done in a one-dimensional way. So if the scores range from 0 to 3, higher scores indicate greater parental self-efficacy, therefore, the range of possible scores on the KPCS is from 0 to 45.
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Feeding Self-Efficacy
To measure food self-efficacy , the Food Self-Efficacy Scale proposed by Chen et al. (2022) will be used, which aims to measure maternal self-confidence in their ability to meet feeding demands and successfully perform feeding behavior. It is made up of 5 items in a single dimension.
The structure to answer each of the questions is through a Likert-type scale, where 4 possible options are presented: 1=Strongly disagree, 2= Disagree, 3= Agree, 4= Strongly agree. Scores range from 1 to 4, higher scores indicate greater food self-efficacy, therefore the range of possible scores on this scale is 4 to 20
Measured: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

Timeline

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

10 Sep 202425 Feb 2025

First posted27 Sep 2024
Study start10 Sep 2024
Primary completion6 Jan 2025
Study completion25 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (39)Papers the sponsor has linked to this study.
Other trials for Prevention Childhood ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The present study will be a phase II intervention study of the pilot clinical trial type because the preliminary effect of an intervention will be evaluated where the Experimental Group (EG) will receive the intervention aimed at increasing the practice of RP and maintaining a healthy weight. The Control Group (CG) will receive the usual care, there will be randomization to both groups through a list with the number of rooms, the pilot clinical trial will be of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later) (Grove, Burns \& Gray, 2015).
Masking: Single blind
Who is masked: Participant
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06617299
Sponsor's protocol ID: FAEN-D-2017
Status last verified: Feb 2025
First submitted: 24 Sep 2024
Last updated: 3 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Personal data will not be shared with other researchers for the protection of personal data included in the study ethics. Only general data derived from the research results will be shared.

Publications

Whitfield KC, Ventura AK. Exploration of Responsive Feeding During Breastfeeding Versus Bottle Feeding of Human Milk: A Within-Subject Pilot Study. Breastfeed Med. 2019 Sep;14(7):482-486. doi: 10.1089/bfm.2019.0069. Epub 2019 Jun 12.
PubMed 31188021
Wen LM, Baur LA, Rissel C, Wardle K, Alperstein G, Simpson JM. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial). BMC Public Health. 2007 May 10;7:76. doi: 10.1186/1471-2458-7-76.
PubMed 17490492
Vilar-Compte M, Perez-Escamilla R, Orta-Aleman D, Cruz-Villalba V, Segura-Perez S, Nyhan K, Richter LM. Impact of baby behaviour on caregiver's infant feeding decisions during the first 6 months of life: A systematic review. Matern Child Nutr. 2022 May;18 Suppl 3(Suppl 3):e13345. doi: 10.1111/mcn.13345. Epub 2022 Apr 1.
PubMed 35363420
Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.
PubMed 29986721
Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.
PubMed 27271455
Ruggiero CF, Hohman EE, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention effects on child appetite and maternal feeding practices through age 3 years. Appetite. 2021 Apr 1;159:105060. doi: 10.1016/j.appet.2020.105060. Epub 2020 Dec 1.
PubMed 33276013
Rossiter MD, Richard B, Whitfield KC, Mann L, McIsaac JD. Responsive feeding values and practices among families across the Canadian Maritime provinces. Appl Physiol Nutr Metab. 2022 May;47(5):495-501. doi: 10.1139/apnm-2021-0692. Epub 2022 Feb 3.
PubMed 35113682
Redsell SA, Slater V, Rose J, Olander EK, Matvienko-Sikar K. Barriers and enablers to caregivers' responsive feeding behaviour: A systematic review to inform childhood obesity prevention. Obes Rev. 2021 Jul;22(7):e13228. doi: 10.1111/obr.13228. Epub 2021 Mar 29.
PubMed 33779040
Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.
PubMed 26459321
Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.
PubMed 24206185
Perez-Escamilla R, Segura-Perez S, Hall Moran V. Dietary guidelines for children under 2 years of age in the context of nurturing care. Matern Child Nutr. 2019 Jul;15(3):e12855. doi: 10.1111/mcn.12855.
PubMed 31240831
Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.
PubMed 25037579
Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.
PubMed 20725058
Pallewaththa P, Agampodi SB, Agampodi TC, Siribaddana SH. Knowledge, Attitudes, and Practices of Responsive Feeding in Rural Sri Lanka (A Qualitative Study). Ceylon Med J. 2019 Jun 30;64(2):70-75. doi: 10.4038/cmj.v64i2.8894.
PubMed 31455070
Paca-Palao A, Huayanay-Espinoza CA, Parra DC, Velasquez-Melendez G, Miranda JJ. [Association between exclusive breastfeeding and obesity in children: a cross-sectional study of three Latin American countries]. Gac Sanit. 2021 Mar-Apr;35(2):168-176. doi: 10.1016/j.gaceta.2019.09.002. Epub 2019 Nov 29. Spanish.
PubMed 31787405

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prevention Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive-Behavioral Intervention Targeting Mothers to Increase Practice of Responsive Feeding and Maintain Healthy Weight in Infants Minors
ClinicalTrials.gov ID: NCT06617299
Acronym / sponsor ID: FAEN-D-2017
Conditions: Prevention Childhood Obesity
Keywords: Infants, Responsive Feeding
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Universidad Autonoma de Nuevo LeonUniversity, hospital or other
Collaborators: Universidad de la Sabana
Study start: 10 Sep 2024 (actual)
Primary completion: 6 Jan 2025 (actual)
Study completion: 25 Feb 2025 (actual)
First posted: 27 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The present study will be a phase II intervention study of the pilot clinical trial type because the preliminary effect of an intervention will be evaluated where the Experimental Group (EG) will receive the intervention aimed at increasing the practice of RP and maintaining a healthy weight. The Control Group (CG) will receive the usual care, there will be randomization to both groups through a list with the number of rooms, the pilot clinical trial will be of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later) (Grove, Burns \& Gray, 2015).

Arm	Type	Receives
Responsive Feeding Group	Experimental	Behavioral: Intervention Identifies and RespondsGroup to receive information on responsive feeding
Breastfeeding Group	No intervention	–Group to receive information disseminated by hospital staff on breastfeeding

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Mother/child dyad, apparently healthy.
Minimum of 12 hours postpartum and/or cesarean section.
Mother who knows how to read and write.
Mother who has a smartphone.
Mother with internet access.

Key exclusion criteria (6 listed)

Hospital stay of the mother/child dyad for more than 7 days after birth.
Child-related exclusions:
Gestational age under 37 weeks (SDG).
Presence of a congenital anomaly.
Physical disability that could affect feeding (e.g., cleft palate, cleft lip).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intervention Identifies and RespondsThe treatment of Experimental Group is described, which is made up of eight individual sessions taught over three months. Session one will be in face-to-face format, the content, resources and activities are described in tables 2 and 3. The remaining seven sessions will be follow-up sessions (four sessions by message (WhatsApp®) where motivational messages and reinforcement information will be sent; and 3 sessions by phone call for feedback, see details of time, content, activities and resources in tables 2 and 3. The design of the intervention is aimed at increasing the practice of Responsive Feeding in mothers with children under 6 months of age, is based on the methodology of Sidani and Braden (2021); on CHW (Bandura, 1986); and behavior change techniques to help people have healthy eating habits (Michie et al., 2011).	Behavioural	Responsive Feeding Group

Primary outcome

Change the practice of responsive feeding in mothers with infants under 6 months of age.
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
To measure the practice of Responsive Feeding in the mother/child dyad, the Feeding Practices and Structure Questionnaire (FPSQ) will be used, a questionnaire in original English designed by Jansen et al., (2022), replicated in the Mexican context (Pérez, 2023). It aims to measure the responsiveness of parents in children under 6 months, mainly breastfed or bottle-fed throughout childhood. It is made up of 18 items divided into 4 dimensions: 1) on-demand feeding, which refers to the fact that the parents make the decision about when the child should be fed; 2) use of food to calm conceptualized as the fact that parents use food to calm or control emotions; 3) persuasive feeding is the fact that parents encourage (pressure) the child to eat more, even when they show signs of satiety; and 4) parent-directed feeding referring to the fact that the parents make the decision (or have a rule) about how long / how much the child feeds.
Healthy weight maintenance in infants
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
The nutritional status of the infant will be analyzed through the indicators of weight/length and BMI/age during birth and follow-up measurements, this according to the WHO and the open-access computer program Anthro®, the patterns of child growth in children under two years of age classified by the z-scores will be used : malnutrition (≤ -2 SD); normal (≥ -1 and ≤ 1 SD); SP (\> 1 and ≤ 2 DE) and OB (≥ 2 DE).

5 secondary outcomes

Mother's Knowledge on the development and feeding practices of the child
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Maternal attitudes Mother's disposition towards infant feeding methods
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Infant temperament
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Parental Self-Efficacy
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Feeding Self-Efficacy
Time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
Background: PubMed 31188021Whitfield KC, Ventura AK. Exploration of Responsive Feeding During Breastfeeding Versus Bottle Feeding of Human Milk: A Within-Subject Pilot Study. Breastfeed Med. 2019 Sep;14(7):482-486. doi: 10.1089/bfm.2019.0069. Epub 2019 Jun 12.
Background: PubMed 17490492Wen LM, Baur LA, Rissel C, Wardle K, Alperstein G, Simpson JM. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial). BMC Public Health. 2007 May 10;7:76. doi: 10.1186/1471-2458-7-76.
Background: PubMed 35363420Vilar-Compte M, Perez-Escamilla R, Orta-Aleman D, Cruz-Villalba V, Segura-Perez S, Nyhan K, Richter LM. Impact of baby behaviour on caregiver's infant feeding decisions during the first 6 months of life: A systematic review. Matern Child Nutr. 2022 May;18 Suppl 3(Suppl 3):e13345. doi: 10.1111/mcn.13345. Epub 2022 Apr 1.
Background: PubMed 29986721Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.
Background: PubMed 27271455Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.
Background: PubMed 33276013Ruggiero CF, Hohman EE, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention effects on child appetite and maternal feeding practices through age 3 years. Appetite. 2021 Apr 1;159:105060. doi: 10.1016/j.appet.2020.105060. Epub 2020 Dec 1.
Background: PubMed 35113682Rossiter MD, Richard B, Whitfield KC, Mann L, McIsaac JD. Responsive feeding values and practices among families across the Canadian Maritime provinces. Appl Physiol Nutr Metab. 2022 May;47(5):495-501. doi: 10.1139/apnm-2021-0692. Epub 2022 Feb 3.
Background: PubMed 33779040Redsell SA, Slater V, Rose J, Olander EK, Matvienko-Sikar K. Barriers and enablers to caregivers' responsive feeding behaviour: A systematic review to inform childhood obesity prevention. Obes Rev. 2021 Jul;22(7):e13228. doi: 10.1111/obr.13228. Epub 2021 Mar 29.
Background: PubMed 26459321Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.
Background: PubMed 24206185Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.
Background: PubMed 31240831Perez-Escamilla R, Segura-Perez S, Hall Moran V. Dietary guidelines for children under 2 years of age in the context of nurturing care. Matern Child Nutr. 2019 Jul;15(3):e12855. doi: 10.1111/mcn.12855.
Background: PubMed 25037579Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.
Ley General de SaludLink provided by the sponsor.
Individual participant dataSharing planned: No. Personal data will not be shared with other researchers for the protection of personal data included in the study ethics. Only general data derived from the research results will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Velia M Cárdenas Villareal, PhD study director

Universidad Autónoma de Nuevo León - Facultad de Enfermería

Gabriela I Martínez Figueroa, Master study chair

Universidad Autónoma de Nuevo León - Facultad de Enfermería

Gloria Carvajal Carrascal, PhD study chair

Universidad de la Sabana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Identifies and Responds in people with Prevention Childhood Obesity, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

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 6 inclusion and 6 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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 the practice of responsive feeding in mothers with infants under 6 months of age. (time frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.). 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 NCT06617299, which also lists 39 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 3 Mar 2025.