Trial Outcomes & Findings for Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers (NCT NCT00635453)

Results Overview

Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

715 participants

Primary outcome timeframe

Six months after the beginning of the study

Results posted on

2021-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	I, Intervention Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Overall Study STARTED	360	355
Overall Study 6 Months Assessment	322	311
Overall Study 12 Months Assessment	285	260
Overall Study 3 Years Assessment	246	204
Overall Study COMPLETED	206	181
Overall Study NOT COMPLETED	154	174

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I, Intervention n=360 Participants Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control n=355 Participants Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.	Total n=715 Participants Total of all reporting groups
Age, Customized < 20 years	72 Participants n=5 Participants	76 Participants n=7 Participants	148 Participants n=5 Participants
Age, Customized > = 20 years	278 Participants n=5 Participants	279 Participants n=7 Participants	557 Participants n=5 Participants
Sex: Female, Male Female	360 Participants n=5 Participants	355 Participants n=7 Participants	715 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	214 Participants n=5 Participants	181 Participants n=7 Participants	395 Participants n=5 Participants
Race/Ethnicity, Customized Non-White	146 Participants n=5 Participants	174 Participants n=7 Participants	320 Participants n=5 Participants
Region of Enrollment Brazil	360 participants n=5 Participants	355 participants n=7 Participants	715 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months after the beginning of the study

Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth.

Outcome measures

Outcome measures
Measure	I, Intervention n=322 Participants Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control n=311 Participants Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Exclusive Breastfeeding at Four Months of Age	140 Participants	104 Participants

SECONDARY outcome

Timeframe: 12 months after the beginning of the study

Population: Analyzed only for participants who underwent anthropometric assessment

The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age

Outcome measures

Outcome measures
Measure	I, Intervention n=263 Participants Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control n=230 Participants Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Number of Overweight Children at 12 Months of Age	124 Participants	112 Participants

SECONDARY outcome

Timeframe: 3 years after the beginning of the study

Population: Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available.

The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age

Outcome measures

Outcome measures
Measure	I, Intervention n=238 Participants Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control n=216 Participants Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Number of Overweight Children at 3 Years of Age	101 Participants	97 Participants

SECONDARY outcome

Timeframe: 6 years after the beginning of the study

Population: Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available.

The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age

Outcome measures

Outcome measures
Measure	I, Intervention n=172 Participants Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. Dietary Advice: The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.	II, Control n=144 Participants Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Number of Overweight Children at 6 Years of Age	52 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Six and twelve months, three and six years after the beginning of the study

Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food)

Outcome measures

Outcome data not reported

Adverse Events

I, Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

II, Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marcia Vitolo

Universidade Federal de Ciências da Saúde de Porto Alegre

Phone: +555133038798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place