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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60311
        • Recruiting
        • Forsa
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Insufficient knowledge of German of the participating family member
  2. 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.
  3. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
  1. Installation of the study app.
  2. At the beginning of the meal, participants 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 participants need 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 participants are instructed to take a picture with their smartphone from the meal table.
  3. A time out from the smartphone starts, meaning that all functions of the phone are locked. The time-out is over as soon as the participant presses the "stop" button.
  4. A short questionnaire about the meal is sent via App to the participating family member when the smartphone is used again.
  5. During the whole period of the study the App tracks the smartphone behavior (i.e., frequency and duration of smartphone use and the specific applications used). Active comparator: control group
Behavioral: Time out from smartphone use during meal time
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.
Behavioral: Control condition
The same as the experimental condition but without a timeout from smartphone use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wuppertal

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Max Planck Institute for Human Development
University of Mannheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Health Behavior

Clinical Trials on Time out from smartphone use during meal time

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings