NCT05276544

Brief Summary

Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic. Because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. Therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

March 3, 2022

Last Update Submit

July 18, 2022

Conditions

Keywords

ObesityWeight LossCOVID-19 pandemic

Outcome Measures

Primary Outcomes (1)

  • Weight chance

    BMI (kilogram/ metre2 (kg/m2))

    At the end of the 3 months

Secondary Outcomes (1)

  • Quality of Life Score

    At the end of the 3 months

Study Arms (3)

phone counseling

EXPERIMENTAL

dietary intervention via phone counseling

Behavioral: Dietary intervention

video counseling

EXPERIMENTAL

dietary intervention via video counseling

Behavioral: Dietary intervention

Traditional follow up

EXPERIMENTAL

dietary intervention via traditional follow up

Behavioral: Dietary intervention

Interventions

Dietary intervention: Preparation and follow-up of diet program.

Traditional follow upphone counselingvideo counseling

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 20-65
  • Being obese (BMI≥30 kg/m2)
  • Having a smartphone with internet access and being competent to use it
  • Volunteering to participate in research

You may not qualify if:

  • Being pregnant/lactating
  • Having a hearing problem
  • Being on a followed diet program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ümüş Özbey

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Weight LossObesityCOVID-19

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • ümüş Ö yücel, Dr

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher of the Amasya University Nutrition and Diet Department

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 11, 2022

Study Start

April 15, 2022

Primary Completion

July 15, 2022

Study Completion

July 18, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations