Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation

NCT07694830 | Not Yet Recruiting

• 1 other identifier: FPTBSUREC/0513/14526
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effect of core-based movement and nutritional counselling on stress, serum cortisol, and lipid profile in overweight women with functional constipation. Sixty overweight women with functional constipation will be randomly assigned into two equal groups. The study group will include 30 participants who will receive a core-based movement exercise program for 8 weeks, two sessions per week, in addition to guideline-based nutritional counselling. The control group will include 30 participants who will receive guideline-based nutritional counselling only for 8 weeks. The outcomes will include perceived stress, serum cortisol level, lipid profile, stool form, sleep quality, and quality of life.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (3)

• Change in Serum Cortisol Level

  Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12-hour overnight fast.

  Baseline and Week 8

• Change in Perceived Stress Score

  Perceived stress will be assessed using the Perceived Stress Scale-10. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress and a worse outcome.

  Baseline and week 8

• Change in Lipid Profile Parameters

  Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol

  Baseline and Week 8

Secondary Outcomes (3)

• Change in Stool Form and Consistency

  Baseline and week 8

• Change in Sleep Quality

  Baseline and week 8

• Change in Health-Related Quality of Life

  Baseline and week 8

Study Arms (2)

Nutritional Counselling Only

ACTIVE COMPARATOR

Each participant in this group will receive NICE- and BDA guideline-based nutritional counselling only for overweight management and functional constipation for 8 weeks.

Behavioral: Guideline-Based Nutritional Counselling

Core-Based Movement and Nutritional Counselling

EXPERIMENTAL

Participants in this group will receive an 8-week core-based movement exercise program, two sessions per week, in addition to NICE- and BDA guideline-based nutritional counselling for overweight management and functional constipation.

Behavioral: Guideline-Based Nutritional Counselling; Behavioral: Core-Based Movement Exercise Program

Interventions

Guideline-Based Nutritional Counselling BEHAVIORAL

Participants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.

Core-Based Movement and Nutritional Counselling; Nutritional Counselling Only

Core-Based Movement Exercise Program BEHAVIORAL

A core-based movement exercise program will include Swan, one leg up-down, leg circles, single-leg stretch, Saw, side kicks, The Hundred, pelvic lift on the ball, sit-ups with the ball, and stretching on the ball. During the first month, sessions 1-8, participants will perform 1 set of 8 repetitions. During the second month, sessions 9-16, participants will perform 2 sets of 10 repetitions. Guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized

Core-Based Movement and Nutritional Counselling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants diagnosed with functional constipation according to Rome IV diagnostic criteria.
• Age between 18 and 45 years.
• Body mass index between 25 and 29.9 kg/m².
• Ability to participate safely in the core-based movement exercise program.
• Willingness to follow the nutritional counselling program and study procedures.

You may not qualify if:

• Participants will be excluded if they have any organic gastrointestinal disorder or any disease that may affect gastrointestinal transit or colonic function.
• Participants with inflammatory bowel disease, concurrent infectious enteritis, malignant tumors, or a history of gastrointestinal surgery, including resection of the stomach, small intestine, or large intestine, will be excluded.
• Participants receiving steroids, antibiotics, immunosuppressive medications, or routinely using laxatives will be excluded.
• Participants with hyperthyroidism, hypothyroidism, or other endocrine or metabolic disorders that may affect gastrointestinal function will be excluded.
• Participants with serious cardiovascular, respiratory, renal, hepatic, hematological, neurological, or psychiatric disorders will be excluded.
• Participants with a history or current evidence of alcohol abuse within the previous year will be excluded.
• Participants currently engaged in an intense workout regimen will be excluded.
• Participants with a musculoskeletal disability that may interfere with exercise applicability, such as cervical or lumbar radiculopathy, will be excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

Central Study Contacts

Doaa M Allam, PhD

CONTACT

01003116041; doaaallam48@gmail.com

Alaa M ElMoatasem, Assistant professor

CONTACT

0 10 06625054; doaaallam48@gmail.com

Study Design

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

Model Details: Participants will be randomly assigned into two parallel groups. The study group will receive core-based movement exercises in addition to guideline-based nutritional counselling, while the control group will receive guideline-based nutritional counselling only. Both groups will be assessed at baseline and after completion of the 8-week intervention.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)