Weight Gain Clinical Trial
— NIELombokOfficial title:
Effectiveness of Post Disaster Nutrition Intervention to Optimize Growth and Development of Under-two-year-old Children in Lombok, Indonesia
In 2018, multiple earthquake with magnitude range from 6 to 7 hit Lombok Island, West Nusa
Tenggara Province, Indonesia. Following the situational analysis and baseline study in
December 2018 (4 months after the first earthquake), it was found that the prevalence of
wasting and underweight of underfive children in the affected population is moderate (10.2%
and 28.8%) but the prevalence of stunting and anemia is considered of highly significant
public health problem (33.3% and 43.8%). Various organizations have provided support at the
emergency phase but there is no specific program for nutrition support at the rehabilitation
phase.
Draft of intervention model which utilize early child education (ECE) centers as center of
nutrition recovery in the community has been discussed with the local education and health
officers. Training will be delivered to ECE teachers and community health officers. ECE
teachers are expected to have regular parenting class for nutrition education and activities,
whilst the community health officers will monitor the activities and provide technical
guidance as needed. Mothers of the underfive children will be invited to attend weekly
parenting class at nearby ECE center in which they receive messages related to infant and
young child feeding (IYCF), including distribution of liver and fish floss as nutrient dense
food supplement to their children, and provision of appropriate psychosocial care.This
parenting class will be held for 6 months with regular monitoring from the researchers and
health personnel from public health center. Effectiveness of the intervention will be
assessed in improving IYCF practices and psychosocial care of mothers and nutrient intakes,
nutritional status and developmental outcomes of the underfives children.
Status | Recruiting |
Enrollment | 480 |
Est. completion date | December 31, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 49 Months |
Eligibility |
Inclusion Criteria: - age ranged between 6-13 months and 24-49 months - live with their mother / main caregiver - parents consent to join the study - live in affected areas Exclusion Criteria: - has chronic / congenital diseases - have sibling that already join the study |
Country | Name | City | State |
---|---|---|---|
Indonesia | Seameo Regional Center for Food and Nutrition | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
SEAMEO Regional Centre for Food and Nutrition | Indonesia University, Ministry of Health, Indonesia |
Indonesia,
Fahmida U, Santika O, Kolopaking R, Ferguson E. Complementary feeding recommendations based on locally available foods in Indonesia. Food Nutr Bull. 2014 Dec;35(4 Suppl):S174-9. — View Citation
Sioen GB, Sekiyama M, Terada T, Yokohari M. Post-Disaster Food and Nutrition from Urban Agriculture: A Self-Sufficiency Analysis of Nerima Ward, Tokyo. Int J Environ Res Public Health. 2017 Jul 10;14(7). pii: E748. doi: 10.3390/ijerph14070748. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | nutritional status | weight gain in g/kg.day | 6 months of intervention | |
Secondary | protein intake | protein intake (gram/day) | 6 months of intervention | |
Secondary | development | Bayley Scales of Infant Development (BSID) as total score (range 0 - >115) | 6 months of intervention | |
Secondary | psycho-social care | HOME Inventory score as total score (range 0-45) | 6 months of intervention | |
Secondary | iron intake | iron intake (mg/day) | 6 months of intervention | |
Secondary | zinc intake | zinc intake (mg/day) | 6 months of intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT05508750 -
Growth and Safety Clinical Trial on a New Infant Formula
|
N/A | |
Not yet recruiting |
NCT03225456 -
Oxytocin and Eating
|
Phase 2 | |
Completed |
NCT02227043 -
Study Of Weight Development Over Time
|
N/A | |
Completed |
NCT01958307 -
Healthy Living in Pregnancy
|
N/A | |
Not yet recruiting |
NCT01916603 -
Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development
|
N/A | |
Completed |
NCT01693666 -
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
|
N/A | |
Completed |
NCT01461824 -
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
|
Phase 3 | |
Terminated |
NCT00759993 -
Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
|
Phase 2 | |
Completed |
NCT00634530 -
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
|
N/A | |
Completed |
NCT00995462 -
Prevention of Weight Gain in University Students
|
N/A | |
Completed |
NCT00122213 -
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
|
Phase 2 | |
Completed |
NCT00306449 -
Prevention of Weight Gain in Young Adults
|
N/A | |
Completed |
NCT03996551 -
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study
|
N/A | |
Recruiting |
NCT03675464 -
Study of Human Adipose Tissue (LOSHAT)
|
||
Completed |
NCT04282655 -
Effect of Milk Warming on the Very Low Birth Weight Infant
|
N/A | |
Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
Completed |
NCT04069351 -
Body Composition Changes During Overfeeding Plus Resistance Training
|
N/A | |
Completed |
NCT00687115 -
Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting
|
Phase 2 |