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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03086811
Other study ID # 0156-11-RMB
Secondary ID
Status Completed
Phase N/A
First received March 16, 2017
Last updated June 5, 2017
Start date October 25, 2011
Est. completion date July 21, 2013

Study information

Verified date June 2017
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rise in childhood obesity and poor eating habits and eating problems is apparent over the last decades. Parents are at lose what the correct way to tackle these problems may be. This study examined whether professional behavioral and nutritional training of first time mothers improves feeding relationship and infants eating habits at 12 months.


Description:

From 166 first time mother-infant recruited, 128 completed the trail. Intervention group, mother-infant dyads got a month long weekly based training in small workshop groups about nutrition, feeding and parenting when infants were 4-6 months old. training was given by a highly experience pediatric dietitian and social worker. Thereafter, internet-based support continued until infants reached 12 months. The control group received customary support via municipal mother-child health clinics. Mealtime interactions were videotaped at home setting at 12 months and were evaluated using the Chatoor feeding scale by blinded (to group) viewers.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date July 21, 2013
Est. primary completion date July 21, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 23 Years to 35 Years
Eligibility Inclusion Criteria:

- normal and healthy pregnancy

- full term delivery of infants

- infants with a normal birth weight and no health problems

- Mothers recruited had at least a high school education

- mothers lived near to or in the city (important for video taping)

Exclusion Criteria:

- Mothers with mental illness in the present or the past (such as schizophrenia, depression or an eating disorder)

- infants with chronic diseases that required specific diets (such as milk allergy) or gastrointestinal diseases (celiac disease, type 1 diabetes, Crohn's disease etc.)

Study Design


Related Conditions & MeSH terms

  • Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention

Intervention

Behavioral:
Mother Infant Feeding Interaction very early training
weekly training meetings on 4 topics: What - proper nutrition and supplements for solid feeding phase (dietitian); What - the meaning of feeding to mother and infant (social worker). Who - feeding skills - knowledge and actual practices From anxiety to serenity - knowledge concerning growth patterns and common physical and emotional issues troubling parents of infants 4-12 months old. Prevention of obesity and emotional eating - practical advise and tips.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

References & Publications (4)

Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14. — View Citation

Bryant-Waugh R, Markham L, Kreipe RE, Walsh BT. Feeding and eating disorders in childhood. Int J Eat Disord. 2010 Mar;43(2):98-111. doi: 10.1002/eat.20795. Review. — View Citation

Meadows N. Assessment and management of feeding difficulties in infants. Community Pract. 2015 Feb;88(2):45-7. — View Citation

Redsell SA, Edmonds B, Swift JA, Siriwardena AN, Weng S, Nathan D, Glazebrook C. Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood. Matern Child Nutr. 2016 Jan;12(1):24-38. doi: 10.1111/mcn.12184. Epub 2015 Apr 20. Review. Erratum in: Matern Child Nutr. 2016 Jul;12(3):643. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Chatoor feeding scale the Chatoor observational scale for Mother-Infant interaction during feeding was purchased from the Chatoor Center. The Scale consists of 46 mother and infant behavior modes which are rated throughout the feeding session. Five subscale scores are derived: 1) Dyadic Reciprocity, 2) Dyadic Conflict, 3) Talk and Distraction, 4) Struggle for Control, and 5) Maternal Non-Contingency. The CFS has been demonstrated to discriminate between infants with and without feeding disorders and can be used with infants and toddlers ranging from 1 month to 3 years of age (Chatoor et al, 1997). 12 months
Secondary eating habitts Self reported questionnaires of Golan et al checking eating habits and obesogenic environment at home 12 months