Health BehaviorOfflineMealsNCT05166252
Are Offline Meals Healthy Meals? A Field Experiment to Promote Healthier Eating in Families
A study testing Time out from smartphone use during meal time in people with Health Behavior and Smartphone Addiction, run by University of Wuppertal at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Smartphone Addiction, Healthy Nutrition
- What is being tested?
- Time out from smartphone use during meal time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jutta Mata, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Forsa
Frankfurt am Main, Hesse, 60311
Mata Jutta, Prof. Dr., mata@uni-mannheim.de
Jutta Mata, Prof. Dr.
About this study
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.
Read the 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.
- Conditions
- Health Behavior, Smartphone Addiction, Healthy Nutrition
- Being tested
- Time out from smartphone use during meal time, Control condition
- Medical subject headings
- Health Behavior, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time out from smartphone use during meal timeBehavioural
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.
Control conditionBehavioural
The same as the experimental condition but without a timeout from smartphone use.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Behavioral: Time out from smartphone use during meal time |
| Control group | Active comparator | Control points in time include all parts as in the experimental group except for number 3. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Un)healthy eating
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.
Measured: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
Parent-child interaction
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.
Measured: Daily Diaries (after Baseline assessment; 14 days in total)
Secondary outcomes (5)
Smartphone use
Objective measurement: An app tracks general smartphone use (duration, frequency of unlocking, which applications were used)
Measured: During the daily Diaries (after Baseline assessment; 14 days in total)
Media use
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.
Measured: Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
Meal duration
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.
Measured: Baseline, During the daily Diaries (after Baseline assessment; 14 days in total)
Technoference
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
Measured: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
Child's distraction
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
Measured: Baseline, Daily Diaries (after Baseline assessment; 14 days in total), Follow up (35 days after the first daily diary assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Nov 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study has an AB/BA crossover design, in which each participant receives the intervention and the control in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuppertal
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Human Development, University of Mannheim
- Responsible party
- Principal investigator, Theda Radtke, University of Wuppertal
- Investigators
- Jutta Mata, Prof. Dr., Principal investigator, University of MannheimMattea Dallacker, Dr., Principal investigator, Max Planck Institute for Human Development, Center for Adaptive RationalityTheda Radtke, Prof. Dr., Principal investigator, Uniersity of Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166252
- Sponsor's protocol ID
- 180831
- Acronym
- OfflineMeals
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to provide the anonymized data set and the coding scheme.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Offline Meals Healthy Meals? A Field Experiment to Promote Healthier Eating in Families
- ClinicalTrials.gov ID
- NCT05166252
- Acronym / sponsor ID
- OfflineMeals / 180831
- Conditions
- Health Behavior, Smartphone Addiction, Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of WuppertalUniversity, hospital or other
- Collaborators
- Max Planck Institute for Human Development, University of Mannheim
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has an AB/BA crossover design, in which each participant receives the intervention and the control in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Time out from smartphone use during meal time1. 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 |
| Control group | Active comparator | Behavioral: Control conditionControl points in time include all parts as in the experimental group except for number 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time out from smartphone use during meal timeOne 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. | Behavioural | Experimental group |
| Control conditionThe same as the experimental condition but without a timeout from smartphone use. | Behavioural | Control group |
Primary outcome
(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.
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.
5 secondary outcomes
Smartphone use
Time frame: 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)
Meal duration
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No. We plan to provide the anonymized data set and the coding scheme.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jutta Mata, Prof. Dr. contact
Jutta Mata, Prof. Dr. principal investigator
University of Mannheim
Mattea Dallacker, Dr. principal investigator
Max Planck Institute for Human Development, Center for Adaptive Rationality
Theda Radtke, Prof. Dr. principal investigator
Uniersity of Wuppertal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time out from smartphone use during meal time in people with Health Behavior and Smartphone Addiction, run by University of Wuppertal at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theda Radtke, Prof. Dr. (+49 202 - 439 5317, radtke@uni-wuppertal.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.