The primary objectives are (1) to investigate the feasibility of online courses targeting nutrition and food-related behaviour and (2) to investigate whether the feasibility of the online courses is related to depressive symptoms. The secondary…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Feasibility of use of online courses and making changes in behaviour (per
intervention; comparison between interventions; comparison between
interventions and control group);
2. Comparison of feasibility in low versus high depressive symptoms group (per
group; comparison between groups)
Secondary outcome
Secondary study parameters will be included as potentially confounding or
modifying variables. These include:
Age
Gender
Country
Socio-demographics: educational level, money available for food, marital
status, ethnic and cultural heritage, work situation, size of household,
number of under-aged children living in the household
Life-style factors: BMI, alcohol use, smoking status, physical activity,
sedentary behaviour, weight status
History of depressive disorder
Eating styles
Social context of eating
Depressive symptoms
Atypical depressive symptoms
Subjective health
Body dissatisfaction
Background summary
Depression is an important risk factor for general public health and strategies
to prevent the development of depression are urgently needed. Nutrition and
food-related behaviour are found to be associated with mental well-being and
depression and might be factors that influence public health. Online
interventions focused on promoting health behaviour are increasing and found to
be effective and useful to reach large populations for preventive purposes.
Knowledge of experiences and preferences of participants is crucial for
successful implementation of these interventions. However, this information is
missing.
In this study, we will explore the feasibility and perceived usefulness of
behaviour change advice targeting nutrition and food-related behaviour. We will
also explore if having depressive symptoms influences the feasibility of these
advices. This is important because having depressive symptoms decreases quality
of life, increases service use and has economic consequences. Furthermore,
people with depressive symptoms have an increased risk of developing major
depression. Feasibility of the nutrition and food-related behaviour advices in
a sample of people with depressive symptoms needs to be investigated, because
having depressive symptoms may reduce motivation for and compliance with
recommendations. Feasible interventions for people with (high) depressive
symptoms are needed in order to prevent negative consequences and the
development of depression. The information of this study can be used to develop
online interventions that are adopted to the level of depressive symptoms and
that reach large groups of people from the general population, without leading
to high numbers of drop-out and that are perceived as easy, both in content and
in adopting the advices.
Study objective
The primary objectives are (1) to investigate the feasibility of online courses
targeting nutrition and food-related behaviour and (2) to investigate whether
the feasibility of the online courses is related to depressive symptoms. The
secondary objective is to investigate the impact of a range of variables on
feasibility outcomes.
Study design
A 8-week randomised controlled trial with 4 intervention groups consisting of
online courses targeted at nutrition and food-related behaviour and one control
group consisting of a online course targeting sustainability. This study is
conducted in both the Netherlands and Denmark.
Intervention
The unguided online courses consist of advice, practical tips and exercises.
Participants can decide for themselves what they want to read, use or fill out.
Study burden and risks
Participants have to follow a 8-week course, of which time investment is
voluntary. Participants fill out online questionnaires at baseline, short
questionnaires after 2,4,6, and 8 weeks, and a final questionnaire after 8
weeks. Post-intervention telephone interviews are conducted in a subsample of
participants who volunteer for this.
Risks are very low, because people with a clinical diagnosis of depression
and/or suicidal tendencies are excluded from participation and the intervention
focuses on normal food products (and food behaviour) and sustainability. The
courses have no therapeutic or diagnostic goal. Standards NEN7510, NEN2712 and
NEN2713 are met.
De Boelelaan 1085
Amsterdam 1081 HV
NL
De Boelelaan 1085
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Aged 18-70 years
Living in the Netherlands or Denmark
BMI 18.5 or higher and lower than 40
Exclusion criteria
Current (in past 6 months) clinical Major Depressive Disorder Episode
Current (in past 6 months) use of antidepressant drugs or psychological interventions
Anxiety or alcohol or substance/drug addiction in previous 6 months
Suicidal intentions as measured during the screening
Diagnosis of bipolar disorder, schizophrenia or psychosis, eating disorder (ever in life)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55581.029.16 |
| Other | NTR23799 |
| OMON | NL-OMON25393 |