Texts For Healthy Teens: A Health Education Program for Adolescents
NCT ID: NCT02809196
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7890 participants
INTERVENTIONAL
2018-10-06
Brief Summary
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Detailed Description
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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:
1. 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
2. Effect of including a friend. Hypothesis 2: Including a friend (versus not including a friend) will increase above effects
3. Effect of including the mother. Hypothesis 3: Including the mother (versus not including the mother) will increase above effects
4. 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
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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1: Tailored, friend and mother
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.
1: Tailored SMS program implicating friend and mother
2: Standardized, friend and mother
The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Friend and mother are invited to participate.
2: Standardized SMS program implicating friend and mother
3:Tailored, friend and not mother
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.
3: Tailored SMS program implicating friend, not mother
4: Standardized, friend and not mother
The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Friend is invited to participate but not mother.
4: Standardized SMS program implicating friend, not mother
5:Tailored, mother and not friend
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.
5: Tailored SMS program implicating mother, not friend
6: Standardized, mother and not friend
The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Mother is invited to participate but not friend.
6: Standardized SMS program implicating mother, not friend
7:Tailored, not friend, not mother
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.
7: Tailored SMS program not implicating mother or friend
8: Standardized, not friend, not mother
The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks.
Neither friend nor mother is invited to participate.
8: Standardized SMS program not implicating mother or friend
9: No SMS program
Control Group; no SMS-based educational program
9: No SMS program
Interventions
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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
6: Standardized SMS program implicating mother, not friend
7: Tailored SMS program not implicating mother or friend
8: Standardized SMS program not implicating mother or friend
9: No SMS program
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
15 Years
ALL
Yes
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Epidemic Health, Inc.
UNKNOWN
Centre for Fetal Programming, Denmark
OTHER
Responsible Party
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Principal Investigators
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Sjurdur F Olsen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Statens Serum Institut
Eric Ding, ScD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Daniel Zoughbie
Role: PRINCIPAL_INVESTIGATOR
Epidemic Health, Inc.
Locations
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Statens Serum Institut
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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2014-01
Identifier Type: -
Identifier Source: org_study_id
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