Food for Mind - Intervention in the Treatment of Depression
Food for Mind - Group-based Behavioral Nutrition Intervention in the Treatment of Depression
1 other identifier
interventional
144
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Nov 2017
Longer than P75 for not_applicable depression
1 active site
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
Study Start
First participant enrolled
November 27, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 17, 2022
November 1, 2022
7.1 years
December 19, 2018
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
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.
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.
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.
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.
12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.
- +1 more secondary outcomes
Other Outcomes (3)
Change from baseline body weight at eight weeks, 6 months and 12 months.
12 months: measured at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline fat mass at eight weeks, 6 months and 12 months.
12 months: measured at baseline, at eight weeks, at 6 months and at 12 months.
Change from baseline fat free mass at eight weeks, 6 months and 12 months.
12 months: measured at baseline, at eight weeks, at 6 months and at 12 months.
Study Arms (2)
Food for Mind -intervention group
ACTIVE COMPARATORNutrition counselling + peer support
Befriending group -control group
ACTIVE COMPARATORSocial activation + peer support
Interventions
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 and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Eastern Finlandlead
- Social Insurance Institution, Finlandcollaborator
- Finnish Cultural Foundationcollaborator
Study Sites (1)
Psychiatric Centre of Kuopio
Kuopio, Northern Savonia, 70600, Finland
Related Publications (1)
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.
PMID: 34001230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Outi M Nuutinen, PhD
Visiting researcher at the unit of Clinical Nutrition, UEF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2018
First Posted
April 5, 2019
Study Start
November 27, 2017
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
November 17, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share