Complementary Feeding RecommendationPhase 2NCT02592109
Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status,Omega-3 Fatty Acids, Malondialdehyde, and Alpha-Tocopherol in Overweight Children in East Jakarta
A Phase 2 study testing Enhanced Counseling using CFR based on Linear Programming in people with Complementary Feeding Recommendation and Linear Programming,, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 Diabetes Mellitus and heart disease. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Complementary Feeding Recommendation, Linear Programming,, Nutritional Status
- What is being tested?
- Enhanced Counseling using CFR based on Linear Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2015to Mar 2016
- Phase
- Phase 2
- 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 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 12-23 months old at first counseling
- body mass index more than +1 standard deviation in WHO Z-score
- parent agree to participate in the study by signing informed consent
Who cannot join
- Children with congenital disease and serious diseases
- Children with parent/caregiver who is illiterate
- Children with parent/caregiver who had communication disability
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Posyandu di Kelurahan Pisangan Timur, Cipinang, Kayuputih, Rawamangun
Jakarta, DKI Jakarta
About this study
Official title: Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status, Omega-3 Fatty Acid, Malondialdehyde, and Alpha-Tocopherol in Children With Risk of Overweight in East Jakarta
The epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive effects leading to the improvement of many diseases related to obesity. Nevertheless, the consumption of this essential nutrient requires certain ration to optimize its favorable result. Although previous studies have examined the efficacy of dietary counseling approach as treatment for obesity, none of them as explicitly explore the use of linear programming to create a tailored diet containing high omega-3 fatty acid food as a part of dietary counseling in obesity management program among children. Thus, this study is intended to contribute the clinical evidence regarding this area of knowledge, specifically the effects of enhanced counseling containing complementary feeding recommendation on nutritional status, omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of overweight aged 12 -23 months in East Jakarta.
Read the detailed description
Randomized-Controlled-Trial with two arms of intervention:
- Control group: receive standard counseling with general existing menu recommendation
- Intervention group: receive enhanced counseling (additional information on omega-3 fatty acids) with population-based menu ganerated from linear programming (LP)
There is a protocol on stratified block randomization. 2 blocks, stratified by: area, age, BMI-for-age status.
Total sample size for analysis:
Overall: 20 control - 18 intervention Blood sample: 18 control - 14 intervention
- Conditions
- Complementary Feeding Recommendation, Linear Programming,, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, Alpha-Tocopherol
- Being tested
- Enhanced Counseling using CFR based on Linear Programming
- Keywords
- Complementary Feeding Recommendation, Linear Programming, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, alpha-Tocopherol
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Counseling using CFR based on Linear ProgrammingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Counseling using CFR based on LP | Experimental | The counseling will be done by individual face-to-face communications. The intervention's arm will get a counseling with an additional of 7-day cycle with adequate n-3 and optimal n-3/6 ratio for complementary feeding menu obtained from linear programming formulation.
The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet; definition, function, and source of omega-3; example of menu that contains adequate omega-3. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks. Receives: Behavioral: Enhanced Counseling using CFR based on Linear Programming |
| General CFR Counseling | Active comparator | The control's arm will get general counseling combining balance diet and IYCF principal, which already been used by Ministry of Health, with additional of 7-day cycle menu guidance modified from existing or available menu which can be downloaded for public on Ministry of Health official website.
The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet based on Ministry of Health's Recommendation, and example of balanced diet menu. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks. Receives: Behavioral: Enhanced Counseling using CFR based on Linear Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Body weight and body height will be used to calculate body mass index
Measured: 10 weeks
Secondary outcomes (3)
Omega-3 Fatty Acid in plasma
Measured: 10 weeks
Malondialdehyde plasma
Measured: 10 weeks
alpha-Tocopherol plasma
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complementary Feeding RecommendationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Responsible party
- Principal investigator, Inge Permadhi, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592109
- Sponsor's protocol ID
- IPermadhi
- Status last verified
- Jun 2016
- First submitted
- 29 Oct 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status, Omega-3 Fatty Acid, Malondialdehyde, and Alpha-Tocopherol in Children With Risk of Overweight in East Jakarta
- ClinicalTrials.gov ID
- NCT02592109
- Acronym / sponsor ID
- IPermadhi
- Conditions
- Complementary Feeding Recommendation, Linear Programming,, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, Alpha-Tocopherol
- Keywords
- Complementary Feeding Recommendation, Linear Programming, Nutritional Status, Omega-3 Fatty Acids, Malondialdehyde, alpha-Tocopherol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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.
The epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive effects leading to the improvement of many diseases related to obesity. Nevertheless, the consumption of this essential nutrient requires certain ration to optimize its favorable result. Although previous studies have examined the efficacy of dietary counseling approach as treatment for obesity, none of them as explicitly explore the use of linear programming to create a tailored diet containing high omega-3 fatty acid food as a part of dietary counseling in obesity management program among children. Thus, this study is intended to contribute the clinical evidence regarding this area of knowledge, specifically the effects of enhanced counseling containing complementary feeding recommendation on nutritional status, omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of overweight aged 12 -23 months in East Jakarta.
Detailed description
Randomized-Controlled-Trial with two arms of intervention:
- Control group: receive standard counseling with general existing menu recommendation
- Intervention group: receive enhanced counseling (additional information on omega-3 fatty acids) with population-based menu ganerated from linear programming (LP)
There is a protocol on stratified block randomization. 2 blocks, stratified by: area, age, BMI-for-age status.
Total sample size for analysis:
Overall: 20 control - 18 intervention Blood sample: 18 control - 14 intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Counseling using CFR based on LP | Experimental | Behavioral: Enhanced Counseling using CFR based on Linear ProgrammingThe counseling will be done by individual face-to-face communications. The intervention's arm will get a counseling with an additional of 7-day cycle with adequate n-3 and optimal n-3/6 ratio for complementary feeding menu obtained from linear programming formulation. The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet; definition, function, and source of omega-3; example of menu that contains adequate omega-3. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks. |
| General CFR Counseling | Active comparator | Behavioral: Enhanced Counseling using CFR based on Linear ProgrammingThe control's arm will get general counseling combining balance diet and IYCF principal, which already been used by Ministry of Health, with additional of 7-day cycle menu guidance modified from existing or available menu which can be downloaded for public on Ministry of Health official website. The counseling consisted of nutritional status in children aged 12-23 months and how to determine the nutritional status; the principle of balanced diet based on Ministry of Health's Recommendation, and example of balanced diet menu. The duration of counseling is approximately 30 minutes, once a week for ten weeks. The mother or caregiver will also receive daily menu for seven days that should be followed during the intervention. The daily menu comprised of 3 main meals and 2 snacks. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 12-23 months old at first counseling
- body mass index more than +1 standard deviation in WHO Z-score
- parent agree to participate in the study by signing informed consent
Key exclusion criteria (3 listed)
- Children with congenital disease and serious diseases
- Children with parent/caregiver who is illiterate
- Children with parent/caregiver who had communication disability
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 |
|---|---|---|
| Enhanced Counseling using CFR based on Linear Programming | Behavioural | Enhanced Counseling using CFR based on LP, General CFR Counseling |
Primary outcome
Nutritional status
Time frame: 10 weeks
Body weight and body height will be used to calculate body mass index
3 secondary outcomes
Omega-3 Fatty Acid in plasma
Time frame: 10 weeks
Malondialdehyde plasma
Time frame: 10 weeks
alpha-Tocopherol plasma
Time frame: 10 weeks
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 22 Jun 2016.
Related trials for Complementary Feeding Recommendation
Recruiting
feediNg gUidelines infanT RandomIzEd coNtrolled Trial
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enhanced Counseling using CFR based on Linear Programming in people with Complementary Feeding Recommendation and Linear Programming,, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 3 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 22 Jun 2016. 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nutritional status (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2016.