Food HabitsT4HTNCT02809196
Texts For Healthy Teens: A Health Education Program for Adolescents
A study testing 1: Tailored SMS program implicating friend and mother, 2: Standardized SMS program implicating friend and mother and 3: Tailored SMS program implicating friend, not mother in people with Food Habits, run by Centre for Fetal Programming, Denmark at 1 site in Denmark.
Trial summary
The overall objective is to examine if participating in an SMS-transmitted health educational program targeting a cluster of dietary factors over a period of weeks during the years of adolescence can induce durable changes towards more healthful dietary habits and body weight trajectories. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Habits
- What is being tested?
- 1: Tailored SMS program implicating friend and mother, 2: Standardized SMS program implicating friend and mother and 3: Tailored SMS program implicating friend, not mother
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,890 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento 6 Oct 2018
- 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 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents participating in the Danish National Birth Cohort
Who cannot join
- Lacking information from maternal interviews 1 and 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Digital Messaging Education Program for Dietary Behavior Modification Towards Healthier Lifestyle Among Danish Adolescents
The overall objective is to examine if participating in an SMS-transmitted health educational program targeting a cluster of dietary factors over a period of weeks during the years of adolescence can induce durable changes towards more healthful dietary habits and body weight trajectories. The investigators will examine if impact is reinforced by asking a friend of the participant to also participate; if impact is reinforced by asking the mother of the participant to also participate; and if impact is reinforced when the SMS-transmitted health promotion program is designed to target a specific dietary factor only - decided upon from participants' reporting of their dietary habits at the beginning of the program - rather than to simultaneously target a cluster of dietary issues uniform for all participants.
Read the detailed description
Groups of adolescents from the Danish National Birth Cohort (DNBC) will be offered to participate in the health educational programs. At 14 years and 14 years plus 3 months all children DNBC are invited to report comprehensively on their dietary and physical activity habits by means of a web-based questionnaire (FFQ). Eligible DNBC adolescents for the SMS-educational program will be invited among those who have completed the FFQ. Thus, once they have completed the DNBC FFQ, they may be invited to participate in the SMS-based educational programs, either addressing only one of the three target factors: sugar sweetened beverages, fruit \& vegetables, or fish (SSB, F\&V, or Fish) or addressing all three factors (cluster). The adolescents may also potentially be invited to include a friend, their mother or both.
Trial Organization:
- Sjurdur F Olsen, MD PhD, Lead Principal Investigator (Responsible Party), Statens Serum Institut, Copenhagen, Denmark;
- Eric Ding, ScD, Co-PI, Harvard TH Chan School of Public Health;
- Daniel Zoughbie, Co-PI, Epidemic Health Inc.
Design for Inviting Adolescents to Educational Program: The study will be conducted corresponding to a '2x2x2 factorial plus 1' design, with 9 arms. In addition to allowing testing of the effect of participating in an SMS based educational program as compared to not participating in such program, this will allow for additional testing of effect of implicating a friend v. not implicating friend; of implicating the mother v. not implicating the mother; and of delivering tailored messaging targeting only one of the three dietary factors (SSB, F\&V, or Fish) v. delivering uniform messaging targeting all three factors.
In the tailored program, the participants will receive messages distributed over 4 weeks, whereas in the FULL program (addressing all three clusters) messages are distributed over 12 weeks. Messages can be divided into five categories: Information, quizzes, tips, challenges, and reminders.
Hypotheses to tested:
- Overall effect. Hypothesis 1: SMS messaging (versus being allocated the group not offered to participate in an SMS messaging program) will improve dietary habits and body weight trajectories
- Effect of including a friend. Hypothesis 2: Including a friend (versus not including a friend) will increase above effects
- Effect of including the mother. Hypothesis 3: Including the mother (versus not including the mother) will increase above effects
- Effect of tailored program v. a cluster of factors. Hypothesis 4: A tailored program will be more efficient than a full program in changing specific outcome.
For testing the hypothesis 4, which addresses one of the three specific, tailored programs (underlined below), eligible adolescents will be stratified into four strata depending on their FFQ response:
Stratum 1: Nearly all participants have a low intake of fish; whereas there will be no problem with sugar sweetened beverages and no problem with fruit and vegetables. Tailored program AND outcome measure to be tested: FISH / fish intake.
Stratum 2: All participants have problems with fruit and vegetables, and no problems with sugar sweetened beverages, but (NB!), like in stratum 1, nearly all have a problem with fish. Tailored program AND outcome measure to be tested: F\&V / intake fruit and vegetable.
Stratum 3: All participants have problems with sugar sweetened beverages; whereas nearly all will have NO problem with fruit and vegetables. Nearly all have a problem with Fish (986/1195). Tailored program AND outcome measure to be tested: SSB / intake of sugar sweetened beverages.
Stratum 4: All participants have a problem with sugar sweetened beverages, fruit and vegetables and fish. Tailored program AND outcome measure to be tested: FISH / fish intake.
Strata 1 \& 4 can be aggregated and, when effect on fish intake is tested, a test for interaction by intake of sugar sweetened beverages or by intake of fruit and vegetables can be made.
A detailed a priori Statistical Analysis Plan SAP (version 2.0) was filed at the Office of Research Integrity, Statens Serum Institut, on June 17, 2019. This date preceded the date of opening the data (i.e., relating the outcome measures to information about which trial arms the adolescents had been randomly allocated to).
- Conditions
- Food Habits
- Being tested
- 1: Tailored SMS program implicating friend and mother, 2: Standardized SMS program implicating friend and mother, 3: Tailored SMS program implicating friend, not mother, 4: Standardized SMS program implicating friend, not mother, 5: Tailored SMS program implicating mother, not friend
- Keywords
- Food Habits, Adolescents, Digital Communication, BMI
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1: Tailored SMS program implicating friend and motherBehavioural
2: Standardized SMS program implicating friend and motherBehavioural
3: Tailored SMS program implicating friend, not motherBehavioural
4: Standardized SMS program implicating friend, not motherBehavioural
5: Tailored SMS program implicating mother, not friendBehavioural
6: Standardized SMS program implicating mother, not friendBehavioural
7: Tailored SMS program not implicating mother or friendBehavioural
8: Standardized SMS program not implicating mother or friendBehavioural
9: No SMS programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1: Tailored, friend and mother | Active comparator | Depending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks.
Friend and mother are invited to participate. Receives: Behavioral: 1: Tailored SMS program implicating friend and mother |
| 2: Standardized, friend and mother | Active comparator | The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Friend and mother are invited to participate. Receives: Behavioral: 2: Standardized SMS program implicating friend and mother |
| 3:Tailored, friend and not mother | Active comparator | Depending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks.
Friend is invited to participate but not mother. Receives: Behavioral: 3: Tailored SMS program implicating friend, not mother |
| 4: Standardized, friend and not mother | Active comparator | The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Friend is invited to participate but not mother. Receives: Behavioral: 4: Standardized SMS program implicating friend, not mother |
| 5:Tailored, mother and not friend | Active comparator | Depending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks.
Mother is invited to participate but not friend. Receives: Behavioral: 5: Tailored SMS program implicating mother, not friend |
| 6: Standardized, mother and not friend | Active comparator | The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Mother is invited to participate but not friend. Receives: Behavioral: 6: Standardized SMS program implicating mother, not friend |
| 7:Tailored, not friend, not mother | Active comparator | Depending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks.
Neither friend nor mother is invited to participate. Receives: Behavioral: 7: Tailored SMS program not implicating mother or friend |
| 8: Standardized, not friend, not mother | Active comparator | The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Neither friend nor mother is invited to participate. Receives: Behavioral: 8: Standardized SMS program not implicating mother or friend |
| 9: No SMS program | Other | Control Group; no SMS-based educational program Receives: Behavioral: 9: No SMS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in an index reflecting overall dietary quality
Based on reported intake in online questionnaires
Measured: 6 months and 18 months after allocation
Change from baseline in BMI z-score
Based on reported height and weight in online questionnaires
Measured: 6 months and 18 months after allocation
Secondary outcomes (3)
Change from baseline in intake of sugar sweetened beverages
Based on reported intake in online questionnaires
Measured: 6 months and 18 months after allocation
Change from baseline in intake of fruits and vegetables
Based on reported intake in online questionnaires
Measured: 6 months and 18 months after allocation
Change from baseline in intake of fish
Based on reported intake in online questionnaires
Measured: 6 months and 18 months after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Primary completion6 Oct 2018
- Study completion6 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 7,890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Fetal Programming, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Epidemic Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Sjurdur F Olsen, Ph.D., Principal investigator, Statens Serum InstitutEric Ding, ScD, Principal investigator, Harvard School of Public Health (HSPH)Daniel Zoughbie, Principal investigator, Epidemic Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809196
- Sponsor's protocol ID
- 2014-01
- Acronym
- T4HT
- Status last verified
- May 2023
- First submitted
- 20 Jun 2016
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bjerregaard AA, Zoughbie DE, Hansen JV, Granstrom C, Strom M, Halldorsson ThornI, Meder IK, Willett WC, Ding EL, Olsen SF. An SMS chatbot digital educational program to increase healthy eating behaviors in adolescence: A multifactorial randomized controlled trial among 7,890 participants in the Danish National Birth Cohort. PLoS Med. 2024 Jun 14;21(6):e1004383. doi: 10.1371/journal.pmed.1004383. eCollection 2024 Jun.
PubMed 38875292
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Messaging Education Program for Dietary Behavior Modification Towards Healthier Lifestyle Among Danish Adolescents
- ClinicalTrials.gov ID
- NCT02809196
- Acronym / sponsor ID
- T4HT / 2014-01
- Conditions
- Food Habits
- Keywords
- Food Habits, Adolescents, Digital Communication, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,890 participants (actual)
- Lead sponsor
- Centre for Fetal Programming, DenmarkUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Epidemic Health, Inc.
- Primary completion
- 6 Oct 2018 (actual)
- Study completion
- 6 Oct 2018 (actual)
- First posted
- 22 Jun 2016 (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 overall objective is to examine if participating in an SMS-transmitted health educational program targeting a cluster of dietary factors over a period of weeks during the years of adolescence can induce durable changes towards more healthful dietary habits and body weight trajectories. The investigators will examine if impact is reinforced by asking a friend of the participant to also participate; if impact is reinforced by asking the mother of the participant to also participate; and if impact is reinforced when the SMS-transmitted health promotion program is designed to target a specific dietary factor only - decided upon from participants' reporting of their dietary habits at the beginning of the program - rather than to simultaneously target a cluster of dietary issues uniform for all participants.
Detailed description
Groups of adolescents from the Danish National Birth Cohort (DNBC) will be offered to participate in the health educational programs. At 14 years and 14 years plus 3 months all children DNBC are invited to report comprehensively on their dietary and physical activity habits by means of a web-based questionnaire (FFQ). Eligible DNBC adolescents for the SMS-educational program will be invited among those who have completed the FFQ. Thus, once they have completed the DNBC FFQ, they may be invited to participate in the SMS-based educational programs, either addressing only one of the three target factors: sugar sweetened beverages, fruit \& vegetables, or fish (SSB, F\&V, or Fish) or addressing all three factors (cluster). The adolescents may also potentially be invited to include a friend, their mother or both.
Trial Organization:
- Sjurdur F Olsen, MD PhD, Lead Principal Investigator (Responsible Party), Statens Serum Institut, Copenhagen, Denmark;
- Eric Ding, ScD, Co-PI, Harvard TH Chan School of Public Health;
- Daniel Zoughbie, Co-PI, Epidemic Health Inc.
Design for Inviting Adolescents to Educational Program: The study will be conducted corresponding to a '2x2x2 factorial plus 1' design, with 9 arms. In addition to allowing testing of the effect of participating in an SMS based educational program as compared to not participating in such program, this will allow for additional testing of effect of implicating a friend v. not implicating friend; of implicating the mother v. not implicating the mother; and of delivering tailored messaging targeting only one of the three dietary factors (SSB, F\&V, or Fish) v. delivering uniform messaging targeting all three factors.
In the tailored program, the participants will receive messages distributed over 4 weeks, whereas in the FULL program (addressing all three clusters) messages are distributed over 12 weeks. Messages can be divided into five categories: Information, quizzes, tips, challenges, and reminders.
Hypotheses to tested:
- Overall effect. Hypothesis 1: SMS messaging (versus being allocated the group not offered to participate in an SMS messaging program) will improve dietary habits and body weight trajectories
- Effect of including a friend. Hypothesis 2: Including a friend (versus not including a friend) will increase above effects
- Effect of including the mother. Hypothesis 3: Including the mother (versus not including the mother) will increase above effects
- Effect of tailored program v. a cluster of factors. Hypothesis 4: A tailored program will be more efficient than a full program in changing specific outcome.
For testing the hypothesis 4, which addresses one of the three specific, tailored programs (underlined below), eligible adolescents will be stratified into four strata depending on their FFQ response:
Stratum 1: Nearly all participants have a low intake of fish; whereas there will be no problem with sugar sweetened beverages and no problem with fruit and vegetables. Tailored program AND outcome measure to be tested: FISH / fish intake.
Stratum 2: All participants have problems with fruit and vegetables, and no problems with sugar sweetened beverages, but (NB!), like in stratum 1, nearly all have a problem with fish. Tailored program AND outcome measure to be tested: F\&V / intake fruit and vegetable.
Stratum 3: All participants have problems with sugar sweetened beverages; whereas nearly all will have NO problem with fruit and vegetables. Nearly all have a problem with Fish (986/1195). Tailored program AND outcome measure to be tested: SSB / intake of sugar sweetened beverages.
Stratum 4: All participants have a problem with sugar sweetened beverages, fruit and vegetables and fish. Tailored program AND outcome measure to be tested: FISH / fish intake.
Strata 1 \& 4 can be aggregated and, when effect on fish intake is tested, a test for interaction by intake of sugar sweetened beverages or by intake of fruit and vegetables can be made.
A detailed a priori Statistical Analysis Plan SAP (version 2.0) was filed at the Office of Research Integrity, Statens Serum Institut, on June 17, 2019. This date preceded the date of opening the data (i.e., relating the outcome measures to information about which trial arms the adolescents had been randomly allocated to).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1: Tailored, friend and mother | Active comparator | Behavioral: 1: Tailored SMS program implicating friend and motherDepending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks. Friend and mother are invited to participate. |
| 2: Standardized, friend and mother | Active comparator | Behavioral: 2: Standardized SMS program implicating friend and motherThe standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks. Friend and mother are invited to participate. |
| 3:Tailored, friend and not mother | Active comparator | Behavioral: 3: Tailored SMS program implicating friend, not motherDepending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks. Friend is invited to participate but not mother. |
| 4: Standardized, friend and not mother | Active comparator | Behavioral: 4: Standardized SMS program implicating friend, not motherThe standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks. Friend is invited to participate but not mother. |
| 5:Tailored, mother and not friend | Active comparator | Behavioral: 5: Tailored SMS program implicating mother, not friendDepending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks. Mother is invited to participate but not friend. |
| 6: Standardized, mother and not friend | Active comparator | Behavioral: 6: Standardized SMS program implicating mother, not friendThe standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks. Mother is invited to participate but not friend. |
| 7:Tailored, not friend, not mother | Active comparator | Behavioral: 7: Tailored SMS program not implicating mother or friendDepending on the responses to the online dietary questionnaire, the tailored SMS-based educational programs can be one out of three different programs, focusing on either sugar sweetened beverages (SSB), fruit and vegetables (F\&V), or fish (FISH). About 40 messages will be distributed over 4 weeks. Neither friend nor mother is invited to participate. |
| 8: Standardized, not friend, not mother | Active comparator | Behavioral: 8: Standardized SMS program not implicating mother or friendThe standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks. Neither friend nor mother is invited to participate. |
| 9: No SMS program | Other | Behavioral: 9: No SMS programControl Group; no SMS-based educational program |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents participating in the Danish National Birth Cohort
Key exclusion criteria (1 listed)
- Lacking information from maternal interviews 1 and 2
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 |
|---|---|---|
| 1: Tailored SMS program implicating friend and mother | Behavioural | 1: Tailored, friend and mother |
| 2: Standardized SMS program implicating friend and mother | Behavioural | 2: Standardized, friend and mother |
| 3: Tailored SMS program implicating friend, not mother | Behavioural | 3:Tailored, friend and not mother |
| 4: Standardized SMS program implicating friend, not mother | Behavioural | 4: Standardized, friend and not mother |
| 5: Tailored SMS program implicating mother, not friend | Behavioural | 5:Tailored, mother and not friend |
| 6: Standardized SMS program implicating mother, not friend | Behavioural | 6: Standardized, mother and not friend |
| 7: Tailored SMS program not implicating mother or friend | Behavioural | 7:Tailored, not friend, not mother |
| 8: Standardized SMS program not implicating mother or friend | Behavioural | 8: Standardized, not friend, not mother |
| 9: No SMS program | Behavioural | 9: No SMS program |
Primary outcome
Change from baseline in an index reflecting overall dietary quality
Time frame: 6 months and 18 months after allocation
Based on reported intake in online questionnaires
Change from baseline in BMI z-score
Time frame: 6 months and 18 months after allocation
Based on reported height and weight in online questionnaires
3 secondary outcomes
Change from baseline in intake of sugar sweetened beverages
Time frame: 6 months and 18 months after allocation
Change from baseline in intake of fruits and vegetables
Time frame: 6 months and 18 months after allocation
Change from baseline in intake of fish
Time frame: 6 months and 18 months after allocation
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 31 May 2023.
- Derived from this study: PubMed 38875292Bjerregaard AA, Zoughbie DE, Hansen JV, Granstrom C, Strom M, Halldorsson ThornI, Meder IK, Willett WC, Ding EL, Olsen SF. An SMS chatbot digital educational program to increase healthy eating behaviors in adolescence: A multifactorial randomized controlled trial among 7,890 participants in the Danish National Birth Cohort. PLoS Med. 2024 Jun 14;21(6):e1004383. doi: 10.1371/journal.pmed.1004383. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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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.
Sjurdur F Olsen, Ph.D. principal investigator
Statens Serum Institut
Eric Ding, ScD principal investigator
Harvard School of Public Health (HSPH)
Daniel Zoughbie principal investigator
Epidemic Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1: Tailored SMS program implicating friend and mother, 2: Standardized SMS program implicating friend and mother and 3: Tailored SMS program implicating friend, not mother in people with Food Habits, run by Centre for Fetal Programming, Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 31 May 2023. 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 Denmark. 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 from baseline in an index reflecting overall dietary quality (time frame: 6 months and 18 months after allocation). 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 NCT02809196, which also lists 1 linked publication.
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 31 May 2023.