Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02809196 |
| Other study ID # |
2014-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Est. completion date |
October 6, 2018 |
Study information
| Verified date |
May 2023 |
| Source |
Centre for Fetal Programming, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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).
