NCT02809196

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 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,890

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2018

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

First QC Date

June 20, 2016

Last Update Submit

May 27, 2023

Conditions

Keywords

Food HabitsAdolescentsDigital CommunicationBMI

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in an index reflecting overall dietary quality

    Based on reported intake in online questionnaires

    6 months and 18 months after allocation

  • Change from baseline in BMI z-score

    Based on reported height and weight in online questionnaires

    6 months and 18 months after allocation

Secondary Outcomes (3)

  • Change from baseline in intake of sugar sweetened beverages

    6 months and 18 months after allocation

  • Change from baseline in intake of fruits and vegetables

    6 months and 18 months after allocation

  • Change from baseline in intake of fish

    6 months and 18 months after allocation

Study Arms (9)

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.

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.

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.

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.

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.

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.

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.

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.

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

9: No SMS program

OTHER

Control Group; no SMS-based educational program

Behavioral: 9: No SMS program

Interventions

1: Tailored, friend and mother
2: Standardized, friend and mother
3:Tailored, friend and not mother
4: Standardized, friend and not mother
5:Tailored, mother and not friend
6: Standardized, mother and not friend
7:Tailored, not friend, not mother
8: Standardized, not friend, not mother
9: No SMS program

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents participating in the Danish National Birth Cohort

You may not qualify if:

  • Lacking information from maternal interviews 1 and 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Statens Serum Institut

Copenhagen, DK-2300, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Primary Completion

October 6, 2018

Study Completion

October 6, 2018

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations