Texts For Healthy Teens: A Health Education Program for Adolescents
Condition: Food Habits
Study type: Interventional

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. 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:

        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).
    

Intervention name(s): 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
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food Habits; Adolescents; Digital Communication; BMI