DepressionNCT03904771
Food for Mind - Intervention in the Treatment of Depression
A study testing Nutrition counselling + peer support and Social activation + peer support in people with Depression, run by University of Eastern Finland at 1 site in Finland.
Trial summary
Aims. The main aim of the study is to explore whether Food for Mind - Group-based behavioral nutrition intervention alleviates depression symptoms. Furthermore, we aim to investigate, whether the intervention improves the quality of diet, eating habits, quality of life, ability to work and to study its… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Nutrition counselling + peer support and Social activation + peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFinland
- Study dates
- 27 Nov 2017to 31 Dec 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 - 65 years
- Customer Relationship of Kuopio Psychiatric Center or City of Kuopio: Individually tailored treatment and rehabilitation plan
- ICD-10 (International Classification of Diseases 10th Revision): Depression Diagnosis (F32-F33, F34.1)
- The treatment (medication and / or psychotherapy) has continued unchanged for at least 2 weeks time before randomization
- Willingness to participate in group-based intervention for 8 weeks: 6 group sessions (5 x 1½h and 1 x 3h)
Who cannot join
- General illness that is clinically unstable and which can be aggravated by intervention
- Pregnancy
- Severe food allergy, intolerance or food aversion
- Participation at the same time, such as other nutrition or exercise intervention
- Primary diagnosis include personality disorder, severe eating disorder and / or substance abuse.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Psychiatric Centre of Kuopio
Kuopio, Northern Savonia, 70600
About this study
Official title: Food for Mind - Group-based Behavioral Nutrition Intervention in the Treatment of Depression
Aims. The main aim of the study is to explore whether Food for Mind - Group-based behavioral nutrition intervention alleviates depression symptoms. Furthermore, we aim to investigate, whether the intervention improves the quality of diet, eating habits, quality of life, ability to work and to study its cost-effectiveness.
In collaboration with 11 public and private health care service providers in cities of Kuopio and Siilinjärvi in Northern Savo, Finland.
Read more
Participants. The total number of subjects will be 144 based on power calculations. The calculation is based on the clinical decline of seven points assessed by the Center for Epidemiologic Studies Depression (CES-D) Scale. Participants sign an informed consent form to participate Food for Mind - intervention.
Study design.
In this randomized controlled clinical trial subjects are randomized into two parallel groups: Food for Mind -behavioral nutrition intervention group (n=72) and Group to bring Good Mood -control group (n=72).
The intervention consists of behavioral nutrition counselling (5 times 1½ h and 1 time 3 h) and the control group (befriending group) (n=72) (5 times 1½ h and 1 time 3 h). Thus, in the befriending group the same visit schedule and length without any nutrition counselling is used. The befriending group consists of discussion of neutral topics, like hobbies, music, sports, and doing together. Both groups continue to have their normal depression care in the health care.
Enrollment and treatment will take about four years, and follow-up will last about one year.
The Northern Savo Hospital District Committee on Research Ethics gave its consent to the study protocol.
Methods. All questionnaires are validated. CES-D -depression scale, Seasonal Pattern Assessment Questionnaire, The Diet Quality Index (IDQ), Diet frequency -questionnaire, Eating competence -questionnaire (ecSI 2.0), The Three Factor Eating Questionnaire, Ability to work and function -questionnaires, Assessment of Quality of Life (AQoL)-8D (8 dimensions) -questionnaire, Treatment expectancy -questionnaire, Acceptability -questioinnaire.
In addition, body composition measurement and cost-effectiveness analyses to evaluate the health outcomes in relation to resource utilization and costs in Food for Mind -intervention.
Read the detailed description
Food for Mind -intervention group - topics of small group meetings
- Getting to know each other and forming a group.
- Overall quality of diet and meal rhythm, shifting thoughts to changing of wishes.
- Nutrition and depression based on the evidence based studies
- Mindful Eating - practical Food for Mind cooking class and eating meal together applying mindful eating
- Food for Mind - getting to know a selection of Food for Mind -food items available in the grocery store.
- Tools for the future: discovering and ensuring your own tools for success to put into action.
Participants in the Food for Mind -intervention group will get for every group meeting optional home exercises consisting of observing their own food habits and bringing "food for mind" items on their meal plan. As a social support, participants can share their own experiences and findings via WhatsApp (Whats Application) messenger -mobile application. The WhatsApp messenger-mobile application is used during the intervention and ten months after it.
The behavioral nutrition counselling is theory-based, i.e. solution focused theory (SFT) and self -determination theory. SFT places responsibility for change in the hands of subjects by using empowering language and recognizing them as skilled in matters of self-care. Subjects have strengths, resources, and coping skills that drive change while generating optimism and hope. Use of basic counseling skills, such as attending and listening, genuineness, empathy, positive regard and reflection, provide the foundation upon which SFT is practised.
- Conditions
- Depression
- Being tested
- Nutrition counselling + peer support, Social activation + peer support
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition counselling + peer supportBehavioural
Behavioral nutrition counselling and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by a nutrition therapist.
Social activation + peer supportBehavioural
Social activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader.
| Study group | Role | What they receive |
|---|---|---|
| Food for Mind -intervention group | Active comparator | Nutrition counselling + peer support Receives: Behavioral: Nutrition counselling + peer support |
| Befriending group -control group | Active comparator | Social activation + peer support Receives: Behavioral: Social activation + peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Depressive Symptomatology at eight weeks, 6 months and 12 months.
Depressive symptomatology measured with the Center for Epidemiologic Studies (CES-D) scale at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
The scale has 20 items and measures symptoms of depression. Each item is scored from 0 (zero) to 3 points. The total score ranges from 0 (zero) to 60 points.Higher values of the total score represent a worse outcome.Four of the items (#4, #8, #12, #16) are reversed before calculating the total score. The total score is calculated as follows: the answers to the items are summed, the sum is divided by the number of scored items, and this value is multiplied by 20. If the answers are missing to more than five items, the total score will not be calculated.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Secondary outcomes (6)
Change from baseline Diet Quality at eight weeks, 6 months and 12 months.
The Diet Quality measured with the Diet Quality Index (IDQ) at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Diet Frequency at eight weeks, 6 months and 12 months.
The Diet Frequency measured with the Diet frequency -questionnaire at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Eating Competence at eight weeks, 6 months and 12 months.
Eating Competence measured with the Eating competence -questionnaire (ecSI 2.0) at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Eating Behavior at eight weeks, 6 months and 12 months.
Eating Behavior measured with The Three Factor Eating Questionnaire at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Ability to Work and Function at eight weeks, 6 months and 12 months.
Ability to Work and Function measured with the Ability to work and function -questionnaires at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Quality of Life at eight weeks, 6 months and 12 months.
The Quality of Life measured with the AQoL-8D -questionnaire at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.
Measured: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start27 Nov 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Finnish Cultural Foundation
- Responsible party
- Sponsor
- Investigators
- Outi M Nuutinen, PhD, Principal investigator, Visiting researcher at the unit of Clinical Nutrition, UEF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904771
- Sponsor's protocol ID
- FoMi
- Status last verified
- Nov 2022
- First submitted
- 19 Dec 2018
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roponen J, Ruusunen A, Absetz P, Partonen T, Kuvaja-Kollner V, Hujo M, Nuutinen O. Nutrition-focused group intervention with a strength-based counseling approach for people with clinical depression: a study protocol for the Food for Mind randomized controlled trial. Trials. 2021 May 17;22(1):344. doi: 10.1186/s13063-021-05279-5.
PubMed 34001230
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food for Mind - Group-based Behavioral Nutrition Intervention in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT03904771
- Acronym / sponsor ID
- FoMi
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Finnish Cultural Foundation
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2019 (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.
Aims. The main aim of the study is to explore whether Food for Mind - Group-based behavioral nutrition intervention alleviates depression symptoms. Furthermore, we aim to investigate, whether the intervention improves the quality of diet, eating habits, quality of life, ability to work and to study its cost-effectiveness.
In collaboration with 11 public and private health care service providers in cities of Kuopio and Siilinjärvi in Northern Savo, Finland.
Participants. The total number of subjects will be 144 based on power calculations. The calculation is based on the clinical decline of seven points assessed by the Center for Epidemiologic Studies Depression (CES-D) Scale. Participants sign an informed consent form to participate Food for Mind - intervention.
Study design.
In this randomized controlled clinical trial subjects are randomized into two parallel groups: Food for Mind -behavioral nutrition intervention group (n=72) and Group to bring Good Mood -control group (n=72).
The intervention consists of behavioral nutrition counselling (5 times 1½ h and 1 time 3 h) and the control group (befriending group) (n=72) (5 times 1½ h and 1 time 3 h). Thus, in the befriending group the same visit schedule and length without any nutrition counselling is used. The befriending group consists of discussion of neutral topics, like hobbies, music, sports, and doing together. Both groups continue to have their normal depression care in the health care.
Enrollment and treatment will take about four years, and follow-up will last about one year.
The Northern Savo Hospital District Committee on Research Ethics gave its consent to the study protocol.
Methods. All questionnaires are validated. CES-D -depression scale, Seasonal Pattern Assessment Questionnaire, The Diet Quality Index (IDQ), Diet frequency -questionnaire, Eating competence -questionnaire (ecSI 2.0), The Three Factor Eating Questionnaire, Ability to work and function -questionnaires, Assessment of Quality of Life (AQoL)-8D (8 dimensions) -questionnaire, Treatment expectancy -questionnaire, Acceptability -questioinnaire.
In addition, body composition measurement and cost-effectiveness analyses to evaluate the health outcomes in relation to resource utilization and costs in Food for Mind -intervention.
Detailed description
Food for Mind -intervention group - topics of small group meetings
- Getting to know each other and forming a group.
- Overall quality of diet and meal rhythm, shifting thoughts to changing of wishes.
- Nutrition and depression based on the evidence based studies
- Mindful Eating - practical Food for Mind cooking class and eating meal together applying mindful eating
- Food for Mind - getting to know a selection of Food for Mind -food items available in the grocery store.
- Tools for the future: discovering and ensuring your own tools for success to put into action.
Participants in the Food for Mind -intervention group will get for every group meeting optional home exercises consisting of observing their own food habits and bringing "food for mind" items on their meal plan. As a social support, participants can share their own experiences and findings via WhatsApp (Whats Application) messenger -mobile application. The WhatsApp messenger-mobile application is used during the intervention and ten months after it.
The behavioral nutrition counselling is theory-based, i.e. solution focused theory (SFT) and self -determination theory. SFT places responsibility for change in the hands of subjects by using empowering language and recognizing them as skilled in matters of self-care. Subjects have strengths, resources, and coping skills that drive change while generating optimism and hope. Use of basic counseling skills, such as attending and listening, genuineness, empathy, positive regard and reflection, provide the foundation upon which SFT is practised.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food for Mind -intervention group | Active comparator | Behavioral: Nutrition counselling + peer supportNutrition counselling + peer support |
| Befriending group -control group | Active comparator | Behavioral: Social activation + peer supportSocial activation + peer support |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20 - 65 years
- Customer Relationship of Kuopio Psychiatric Center or City of Kuopio: Individually tailored treatment and rehabilitation plan
- ICD-10 (International Classification of Diseases 10th Revision): Depression Diagnosis (F32-F33, F34.1)
- The treatment (medication and / or psychotherapy) has continued unchanged for at least 2 weeks time before randomization
- Willingness to participate in group-based intervention for 8 weeks: 6 group sessions (5 x 1½h and 1 x 3h)
Key exclusion criteria (5 listed)
- General illness that is clinically unstable and which can be aggravated by intervention
- Pregnancy
- Severe food allergy, intolerance or food aversion
- Participation at the same time, such as other nutrition or exercise intervention
- Primary diagnosis include personality disorder, severe eating disorder and / or substance abuse.
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 |
|---|---|---|
| Nutrition counselling + peer supportBehavioral nutrition counselling and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by a nutrition therapist. | Behavioural | Food for Mind -intervention group |
| Social activation + peer supportSocial activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader. | Behavioural | Befriending group -control group |
Primary outcome
Change from baseline Depressive Symptomatology at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Depressive symptomatology measured with the Center for Epidemiologic Studies (CES-D) scale at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group. The scale has 20 items and measures symptoms of depression. Each item is scored from 0 (zero) to 3 points. The total score ranges from 0 (zero) to 60 points.Higher values of the total score represent a worse outcome.Four of the items (#4, #8, #12, #16) are reversed before calculating the total score. The total score is calculated as follows: the answers to the items are summed, the sum is divided by the number of scored items, and this value is multiplied by 20. If the answers are missing to more than five items, the total score will not be calculated.
6 secondary outcomes
Change from baseline Diet Quality at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Diet Frequency at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Eating Competence at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Eating Behavior at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Ability to Work and Function at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline Quality of Life at eight weeks, 6 months and 12 months.
Time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 34001230Roponen J, Ruusunen A, Absetz P, Partonen T, Kuvaja-Kollner V, Hujo M, Nuutinen O. Nutrition-focused group intervention with a strength-based counseling approach for people with clinical depression: a study protocol for the Food for Mind randomized controlled trial. Trials. 2021 May 17;22(1):344. doi: 10.1186/s13063-021-05279-5.
- Individual participant dataSharing planned: No
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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.
Outi M Nuutinen, PhD principal investigator
Visiting researcher at the unit of Clinical Nutrition, UEF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition counselling + peer support and Social activation + peer support in people with Depression, run by University of Eastern Finland at 1 site in Finland.
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 5 inclusion and 5 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 17 Nov 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 Finland. 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 Outi M Nuutinen, PhD (+358 50 4691779, Outi.Nuutinen@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Depressive Symptomatology at eight weeks, 6 months and 12 months. (time frame: 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904771, which also lists 1 linked publication.
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 17 Nov 2022.