- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05166252
Are Offline Meals Healthy Meals? A Field Experiment to Promote Healthier Eating in Families (OfflineMeals)
December 22, 2021 updated by: Theda Radtke, University of Wuppertal
First research findings suggest that the influence of digital media on children's and adolescents' health depends primarily on proper use and regulation.
In line with Social Cognitive Theory, parents' own mobile device use is very important to regulate children's media use because parents are their children's role models.
However, parents do not always behave as optimal role models: They use smartphones on playgrounds, in restaurants, as well as during family mealtimes.
This usage of mobile devices leads to interruptions during face-to-face conversations or routines which is defined as "technoference".
Studies among children and parents suggest that parental mobile device use is associated with fewer parent-child interactions.
In addition, first studies investigated mobile device use at the dining table and showed that mothers had less interactions with their children during meal times when they used a mobile device compared to mothers who did not and their children were also less likely to try new and unfamiliar food.
Along the same lines, lower parental mobile device use during mealtime is also associated with healthier body weight in children.
AIM: Examination of the effect of a time out from smartphone use during a family meal on the parent-child interaction at the meal table and eating quality in comparison to family meals where participants use the smartphone as usual.
DESIGN: The study is a within-family field experiment with daily assessments over 14 days (7 days for the experimental condition, 7 days for the control condition).
Families will go through both, intervention and control condition with a break of 21 days in between.
The assessment of the main and secondary outcomes is conducted at the baseline, over a 14 day daily diary phase and at the follow-up (directly after the daily diary phase).
The sample will consist of 120 families with at least one child between the age of 6 to 14 years old.
Only the participating adult in the study fills in the questionnaires.
OUTCOMES: (Un)healthy eating and parent-child interaction constitute the main outcome, whereas technoference, mealtime duration, atmosphere at the meal table, and smartphone use frequency are secondary outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Emerging mobile and digital technologies such as smartphones, tablets, wearables, and other mobile devices are an integral part in the daily lives of children, adolescents, and their families.
The intensive use of mobile devices has both, positive aspects and negative side effects: The main advantages include access to information and making it easy to maintain social relationships.
Potentially harmful risks for children include delays in small children's speech development, concentration disorders in primary school aged children or an increased consumption of sweet drinks and sweets.
Especially parental media supervision is needed to regulate children's media use.
In line with Social Cognitive Theory, parents' own mobile device use is also very important to regulate children's media use because parents are their children's role models.
However, parents do not always behave as optimal role models: They use smartphones on playgrounds, as well as during family mealtimes.
This usage of mobile devices leads to interruptions during face-to-face conversations or routines which is defined as "technoference".
Studies among children and parents suggest that parental mobile device use is associated with fewer parent-child interactions.
Especially using smartphones during shared meals could negatively influence interactions at the dining table as well as healthy eating habits in children.
First findings suggest that the use of smartphones during family meals has detrimental effects on the family meal itself (e.g., interactions) as well as the health of the family members (e.g., diet quality and body weight).
Importantly, these studies are all observational or cross-sectional, thus, experimental research is needed to understand whether taking the smartphone away from the family meal will actually lead to better interactions and healthier meals.
While some experts suggest to ban smartphones from the dinner table, no one has systematically tested the effects.
Thus, the aim of the proposed study is to experimentally test the effects of using smartphones at family meals versus banning them from the meal table and to examine potential mechanisms underlying this relation.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Theda Radtke, Prof. Dr.
- Phone Number: +49 202 - 439 5317
- Email: radtke@uni-wuppertal.de
Study Contact Backup
- Name: Jutta Mata, Prof. Dr.
- Email: mata@uni-mannheim.de
Study Locations
-
-
Hessen
-
Frankfurt am Main, Hessen, Germany, 60311
- Recruiting
- Forsa
-
Contact:
- Mata Jutta, Prof. Dr.
- Email: mata@uni-mannheim.de
-
Principal Investigator:
- Jutta Mata, Prof. Dr.
-
Principal Investigator:
- Mattea Dallacker, Dr.
-
Principal Investigator:
- Theda Radtke, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- One parent who 1. lives in a household with at least one child aged between 6 and 14 years 2. eats a family meal (shared meal) with this child at least 5 days/week 3. owns an Android smartphone 4. has mobile internet on the smartphone 5. uses the smartphone on a daily basis 6. uses the smartphone at least sometimes during shared meals 5. agrees on participating in the study.
Exclusion Criteria:
- Insufficient knowledge of German of the participating family member
- Involvement of the participating family member and/or child in a dietary program to reduce weight or plan to do so for the duration of the study.
- Holidays during the intervention period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
|
One parent will be instructed to install a study app.
Further, he/she press a button within the App to start a time out from the smartphone at the beginning of a meal (i.e.
calls and message are blocked and the parent needs to press an extra button in order to leave the app).
The app instructs all other family members to turn off their phones and to put them away.
Then, the parent is instructed to take a picture with their smartphone from the "smartphone-free family meal table" .
The time-out is over as soon as the parent presses the "stop" button.
|
Active Comparator: Control group
Control points in time include all parts as in the experimental group except for number 3.
|
The same as the experimental condition but without a timeout from smartphone use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Un)healthy eating
Time Frame: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Self-reported (un)healthy eating measured via intake of portions of fruits and vegetables, desserts, and sugar-sweetened beverages per day per child.
Items according to Flückiger, L., Lieb, R., Meyer, A. H., Witthauer, C., & Mata, J. (2017).
Day-to-day variations in health behaviors and daily functioning: Two intensive longitudinal studies.
Journal of Behavioral Medicine, 40, 307-319.
|
Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Parent-child interaction
Time Frame: Daily Diaries (after Baseline assessment; 14 days in total)
|
Parent-child interaction.
Items according to: Mata, J., Dallacker, M., & Hertwig, R. (2018).
A matter of time: Longer meal duration increases healthy eating in children.
An experimental study.
Invited presentation, conference of the German Society for Psychology, Frankfurt/ Main, Germany.
|
Daily Diaries (after Baseline assessment; 14 days in total)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smartphone use
Time Frame: During the daily Diaries (after Baseline assessment; 14 days in total)
|
Objective measurement: An app tracks general smartphone use (duration, frequency of unlocking, which applications were used)
|
During the daily Diaries (after Baseline assessment; 14 days in total)
|
Media use
Time Frame: Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
|
Media use during meal time is measured with items from Knobl, V., Dallacker, M., Hertwig, R., & Mata, J. (manuscript submitted for publication).
Happy and healthy: How family mealtime routines relate to child nutritional health.
|
Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
|
Meal duration
Time Frame: Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
|
Meal duration is measured with one item according to Knobl, V., Dallacker, M., Hertwig, R., & Mata, J. (manuscript submitted for publication).
Happy and healthy: How family mealtime routines relate to child nutritional health.
|
Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
|
Technoference
Time Frame: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Technoference is measured according to McDaniel, B. T., & Coyne, S. M. (2016).
"Technoference": The interference of technology in couple relationships and implications for women's personal and relational well-being.
Psychology of Popular Media Culture, 5, 85-98.
doi: 10.1037/ppm0000065
|
Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Child's distraction
Time Frame: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Child's distraction is measured according to McDaniel, B. T., & Coyne, S. M. (2016).
"Technoference": The interference of technology in couple relationships and implications for women's personal and relational well-being.
Psychology of Popular Media Culture, 5, 85-98.
doi: 10.1037/ppm0000065
|
Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jutta Mata, Prof. Dr., University of Mannheim
- Principal Investigator: Mattea Dallacker, Dr., Max Planck Institute for Human Development, Center for Adaptive Rationality
- Principal Investigator: Theda Radtke, Prof. Dr., Uniersity of Wuppertal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 20, 2021
First Submitted That Met QC Criteria
December 20, 2021
First Posted (Actual)
December 21, 2021
Study Record Updates
Last Update Posted (Actual)
January 3, 2022
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180831
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We plan to provide the anonymized data set and the coding scheme.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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