Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Social Insurance Institution, Finland | OTHER |
| Finnish Cultural Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Food for Mind -intervention group - topics of small group meetings
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food for Mind -intervention group | Active Comparator | Nutrition counselling + peer support |
|
| Befriending group -control group | Active Comparator | Social activation + peer support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition counselling + peer support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline body weight at eight weeks, 6 months and 12 months. | Body weight measured by body composition analyzer (InBody720) at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group. | 12 months: measured at baseline, at eight weeks, at 6 months and at 12 months. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Outi M Nuutinen, PhD | Contact | +358 50 4691779 | Outi.Nuutinen@uef.fi | |
| Johanna A Roponen, MSci, RD | Contact | +358 44 245 1211 | ruokaamielelle@uef.fi |
| Name | Affiliation | Role |
|---|---|---|
| Outi M Nuutinen, PhD | Visiting researcher at the unit of Clinical Nutrition, UEF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Centre of Kuopio | Recruiting | Kuopio | Northern Savonia | 70600 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001230 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Social activation + peer support | Behavioral | Social activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader. |
|
| 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. |
| 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. | 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. | 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. | 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. | 12 months: assessed 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. |
Fat mass measured by body composition analyzer (InBody720) at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group. |
| 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. | Fat free mass measured by body composition analyzer (InBody720) at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group. | 12 months: measured at baseline, at eight weeks, at 6 months and at 12 months. |