NCT04802525

Brief Summary

It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Hence, we assessed the potential influences of a low-fat diet combined with MIAET on blood lipids and depression in those individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 15, 2021

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    The height and weight were assessed using an electronic digital scale and consequently BMI was calculated

    10 weeks

Study Arms (3)

Moderate-intensity aerobic exercise training without dietary control group

EXPERIMENTAL
Other: Moderate-intensity aerobic exercise training

Low-fat diet program without exercise intervention group

EXPERIMENTAL
Other: Moderate-intensity aerobic exercise training

Moderate-intensity aerobic exercise training plus a low-fat diet program group

EXPERIMENTAL
Other: Moderate-intensity aerobic exercise training

Interventions

The first group has received Moderate-intensity aerobic exercise training without dietary control, the second group has received a low-fat diet program without exercise intervention, and the third group has received Moderate-intensity aerobic exercise training plus a low-fat diet program for 10 consecutive weeks

Low-fat diet program without exercise intervention groupModerate-intensity aerobic exercise training plus a low-fat diet program groupModerate-intensity aerobic exercise training without dietary control group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age of 30-50 years
  • clinical diagnosis with obesity (BMI˃30)
  • mild to moderate depression
  • impaired blood lipids
  • no use of medications last 6-12 months
  • no smoking

You may not qualify if:

  • neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
  • severe depression
  • patients using medications of dyslipidemia, depression, or obesity last 6-12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 17, 2021

Study Start

October 10, 2019

Primary Completion

January 2, 2020

Study Completion

January 15, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations