NCT03904771

Food for Mind - Intervention in the Treatment of Depression

Status unknown NA Last updated 17 November 2022

What this trial tests

NA trial testing Nutrition counselling + peer support in Depression in 144 participants. Status unknown.

Timeline

27 November 2017

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	University of Eastern Finland
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	144
Start date	27 November 2017
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across Finland

Drugs / interventions tested

• Nutrition counselling + peer support
• Social activation + peer support

Conditions studied

• Depression — all drugs for Depression →

Sponsor

University of Eastern Finland

Who can join

Adults 20 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Roponen J, Ruusunen A, Absetz P, Partonen T, et al · · 2021 · cited 4× · PMID 34001230 · DOI 10.1186/s13063-021-05279-5