NCT02398253

Brief Summary

The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2015

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

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

March 20, 2015

Last Update Submit

October 24, 2019

Conditions

ObesityOverweight

Keywords

weight maintenancecognitive behavior therapysuccessful weight loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    24 Weeks

Secondary Outcomes (5)

  • Fasting plasma glucose level

    24 weeks

  • lipid profiles

    48 weeks

  • Insulin resistance(HOMA)

    24 weeks

  • Waist circumference

    24 Weeks

  • Body mass index reduction

    24 Weeks

Study Arms (2)

CBT + Hypo-energetic Diet

EXPERIMENTAL
Behavioral: CBT + Hypo-energetic Diet

Hypo-energetic Diet only

EXPERIMENTAL
Behavioral: Hypo-energetic Diet only

Interventions

CBT + Hypo-energetic DietBEHAVIORAL

This group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.

CBT + Hypo-energetic Diet
Hypo-energetic Diet onlyBEHAVIORAL

This group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.

Hypo-energetic Diet only

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
  • Must be able to have moderate exercise.
  • Must be interested to keep weight loss.

You may not qualify if:

  • Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
  • Taking medications that could affect metabolism or change body weight.
  • Report heart problems, chest pain, and cancer within the last five years.
  • Smoking
  • Menopause
  • Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, 1913635136, Iran

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hamid R Farshchi, MD, PhD

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    STUDY CHAIR

  • Ameneh Madjd, Dr.

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Ian A Macdonald, Prof.

    School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Moira A Taylor, PhD

    School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Reza Malekzadeh, Prof.

    Digestive Disease Research Institute, Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Alireza Delavari, MD

    Digestive Disease Research Institute, Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 25, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

IR(1)