Effect of Weight Reduction on Constipation

NCT03106857 | Completed DMC

• 1 other identifier: P.T. REC/012/001535
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• Physical activity and constipation relationship

  11 months

Study Arms (2)

Group A

PLACEBO COMPARATOR

Physical activity, a low caloric diet, and the routine standard care for constipation

Other: Group A

Group B

NO INTERVENTION

No intervention

Interventions

Group A OTHER

Group A Physical activity and low caloric diet for

Group A

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients whose BMI exceeded 30 kg/m2 were included.
• In addition, they fulfilled the ROM criteria of constipation, as follows:
• Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis:
• straining during at least 25% of defecations,
• lumpy or hard stools in at least 25% of defecations,
• sensation of incomplete evacuation for at least 25% of defecations,
• sensation of anorectal obstruction/blockage for at least 25% of defecations,
• requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and
• fewer than 3 defecations per week;
• Loose stools rarely occurred without the use of laxatives;
• Insufficient criteria for irritable bowel syndrome; and
• Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.

You may not qualify if:

• Patients with metabolic, endocrine, and neurologic constipation;
• current or past smokers;
• those with any orthopedic limitation; and
• those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study.
• Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded.

Sponsors & Collaborators

• Ahlia University: lead
• Cairo University: collaborator

Study Sites (2)

Dr Dalia Kamel

Giza, Giza Governorate, Egypt

Location

Dr Sayed Tanatwy

Giza, Giza Governorate, Egypt

Location

Study Officials

• Sayed A Tantawy, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 11, 2017
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)