T4HT: Texts For Healthy Teens: A Health Education Program for Adolescents

Sponsor
Centre for Fetal Programming, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT02809196
Collaborator
Harvard School of Public Health (HSPH) (Other), Epidemic Health, Inc. (Other)
8,000
1
9
18
444.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 1: Tailored SMS program implicating friend and mother
  • Behavioral: 2: Standardized SMS program implicating friend and mother
  • Behavioral: 3: Tailored SMS program implicating friend, not mother
  • Behavioral: 4: Standardized SMS program implicating friend, not mother
  • Behavioral: 5: Tailored SMS program implicating mother, not friend
  • Behavioral: 6: Standardized SMS program implicating mother, not friend
  • Behavioral: 7: Tailored SMS program not implicating mother or friend
  • Behavioral: 8: Standardized SMS program not implicating mother or friend
  • Behavioral: 9: No SMS program
N/A

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), SSI

  • 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 will improve dietary habits 1a) tailored 1b) non- tailored

  2. Effect of including a friend. Hypothesis 2: Including a friend will increase above effects 2a) tailored 2b) non- tailored

  3. Effect of including the mother. Hypothesis 3: Including the mother will increase above effects 3a) tailored 3b) non- tailored

  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 this hypothesis, 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8000 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Official Title:
A Digital Messaging Education Program for Dietary Behavior Modification Towards Healthier Lifestyle Among Danish Adolescents
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: 1: Tailored SMS program implicating friend and mother

Active Comparator: 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.

Behavioral: 2: Standardized SMS program implicating friend and mother

Active Comparator: 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.

Behavioral: 3: Tailored SMS program implicating friend, not mother

Active Comparator: 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.

Behavioral: 4: Standardized SMS program implicating friend, not mother

Active Comparator: 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.

Behavioral: 5: Tailored SMS program implicating mother, not friend

Active Comparator: 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.

Behavioral: 6: Standardized SMS program implicating mother, not friend

Active Comparator: 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.

Behavioral: 7: Tailored SMS program not implicating mother or friend

Active Comparator: 8: Standardized, not friend, not mother

The standardized SMS-based educational program includes 121 messages there will be distributed over 12 weeks. Mother is invited to participate but not friend. Neither friend nor mother is invited to participate.

Behavioral: 8: Standardized SMS program not implicating mother or friend

Other: 9: No SMS program

Control Group; no SMS-based educational program

Behavioral: 9: No SMS program

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in intake of sugar sweetened beverages [6 months and 12 months after allocation]

    Based on reported intake in online questionnaires

  2. Change from baseline in intake of fruits and vegetables [6 months and 12 months after allocation]

    Based on reported intake in online questionnaires

  3. Change from baseline in intake of fish [6 months and 12 months after allocation]

    Based on reported intake in online questionnaires

  4. Change from baseline in an index reflecting overall dietary quality [6 months and 12 months after allocation]

    Based on reported intake in online questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adolescents participating in the Danish National Birth Cohort
Exclusion Criteria:
  • Lacking information from maternal interviews 1 and 2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Statens Serum Institut Copenhagen Denmark DK-2300

Sponsors and Collaborators

  • Centre for Fetal Programming, Denmark
  • Harvard School of Public Health (HSPH)
  • Epidemic Health, Inc.

Investigators

  • Principal Investigator: Sjurdur F Olsen, Ph.D., Statens Serum Institut
  • Principal Investigator: Eric Ding, ScD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Daniel Zoughbie, Epidemic Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre for Fetal Programming, Denmark
ClinicalTrials.gov Identifier:
NCT02809196
Other Study ID Numbers:
  • 2014-01
First Posted:
Jun 22, 2016
Last Update Posted:
Nov 15, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Centre for Fetal Programming, Denmark

Study Results

No Results Posted as of Nov 15, 2016