- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04708379
Lifestyle Interventions for Overweight Adults With Mental Illness
Lifestyle Interventions for Overweight Adults With Severe Mental Illness in Shenzhen, China
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Previous studies suggest that overweight is an important risk factor for life quality and mental health among patients with severe mental illness. Findings on Chinese adults regarding this issue are limited. Thus, we aim to assess the lifestyle intervention on life quality and mental health among overweight adults with severe mental illness in Shenzhen, China.
A total of 210 overweight adults with severe mental illness will be randomly allocated to two groups. Participants in the intervention groups will receive a 10-month lifestyle intervention while the control group will be waitlisted.
In the intervention group, participants will receive lifestyle education delivered by trained staffs from Wuhan university. The main objective of the lifestyle education is to raise participants' awareness regarding the health complications related to obesity and subsequently to promote weight loss through behavioural modifications. Participants will be advised to reduce energy intake by having three main meals and avoiding snacks; limiting intake of sugary food and beverages as well as fried and fatty foods; increasing intake of fruits and vegetables, etc. They will be asked to increase physical activity, aiming for a minimum 150 min of moderate-intensity exercise per week and/or 10,000 steps per day.
Outcome measurement include height, weight, blood pressure, dietary habits, sleep, physical activity, life quality, and mental health that will be measured by a group of trained investigator for all participants.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Guangdong
-
Shenzhen, Guangdong, Kina, 518118
- Pingshan CDC
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18-65 years
- With severe mental illness
- BMI>=24.0
- Live in this district for 1 year at least.
Exclusion Criteria:
- Disability
- Refuse to participate
- Pregnant woman
- Severe chronic diseases, such as cancer.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intervention group
Nutrition education and physical activity education.
|
Nutrition and physical activity education.
|
Ingen inngripen: Control group
No specific intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
BMI
Tidsramme: 12 weeks
|
Participants' height (in meters) and weight (in kilograms) will be measured by a group of investigators.
weight and height will be combined to report BMI in kg/m^2.
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Life quality
Tidsramme: 12 weeks
|
Life quality will be investigated by the short form version of the quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-SF).
Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good).
A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
|
12 weeks
|
Depression
Tidsramme: 12 weeks
|
Depression will be assessed by Center for Epidemiological Studies Depression Scale (CES-D).
This is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression.
Response options range from 0 to 3 for each item.
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
|
12 weeks
|
Social support
Tidsramme: 12 weeks
|
Social support will be assessed by Perceived social support scale(PSSS).
The scale consists of 12 items, including family support, friend support and other support.
The higher the score of Liker-7 points, the higher the level of social support perceived by the individual.
|
12 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
BP
Tidsramme: 12 weeks
|
Blood pressure (measured by a group of investigators)
|
12 weeks
|
Sleep
Tidsramme: 12 weeks
|
Sleep status will be assessed by Pittsburgh Sleep Quality Index (PSQI).
The PSQI is a self-report questionnaire consisting of 19 items and five additional questions.
The 19 items are combined to form seven sleep quality component scores.
Each component score can range from 0 to 3. The seven component scores are summed to yield a global PSQI score ranging from 0 to 21, with higher scores indicate poorer sleep quality.
|
12 weeks
|
Physical activity
Tidsramme: 12 weeks
|
Physical activity will be assessed by International Physical Activity Questionnaire (IPAQ).
This IPAQ consists of seven questions assessing the frequency and duration of participation in vigorous, moderate-intensity, and walking activity as well as the time spent sitting during a weekday.
The sum of the three activity scores gives an indicator of total physical activity.
|
12 weeks
|
Diet
Tidsramme: 12 weeks
|
Participants self-report their dietary intake including rice, meat, milk, fruits, vegetable, etc using a short food frequency questionnaire.
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Qiqiang He, PhD, Wuhan University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pingshan Mental Health Study
Plan for individuelle deltakerdata (IPD)
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