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The efficacy of Psycho-Physical Intervention for obesity and weight-reduction among women- A randomized controlled trial

The efficacy of Psycho-Physical Intervention for obesity and associated factors among women- A randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001104246
Enrollment
105
Registered
2018-07-03
Start date
2016-11-19
Completion date
2017-01-07
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The current study aims to measure effectiveness of psychological plus physical interventions for obesity and associated factors. The psycho-physical interventions are combinations of cognitive behavior therapy (CBT) plus exercise plus diet management to reduce obesity diagnostic factors such as body weight, body mass index (BMI), waist-to-hip ratio (WHR), and percent body fat (PBF) among women. The same intervention targeted obesity associated factors such as eating behavior, sedentary behavior, body image, and self-control. Through a randomized control trial repeated measure design, the current study recruited one-hundred and twenty-eight females (N=128) from South Punjab, Pakistan by employing penal data technique with purposive sampling on the basis of inclusion criteria (BMI>25 kg/m2). The sample distributed into four equal groups through online permuted block randomization. The experimental group-1 (CBT + Exercise) received 10-week sessions of cognitive behavior therapy along with exercise execution during intervention phase. Further, the experimental group-2 (CBT + Diet) received 10-week sessions of cognitive behavior therapy with diet management plan. The next experimental group-3 (CBT + Exercise + Diet) also received 10-week sessions of CBT along with exercise execution and diet plan. The last group-4 (control) attend 10-week sessions but information only. Outcomes were measured at baseline, 4th week, 8th week, and 10th week as an intervention phase, and 30th week as an follow-up phase.

Interventions

This trial has three intervention groups (CBT + Exercise, CBT + Diet, CBT + Exercise + Diet), and two phases (10-week intervention-phase and 5-month follow-up phase). This is psycho-physical intervention in the form of cognitive behavior therapy, exercise regimen and diet plan for obesity and associated factors management. The selected associated factors of obesity are eating behavior, sedentary behavior, body image, and self-control. The “CBT + Exercise” intervention consists of cognitive be

This trial has three intervention groups (CBT + Exercise, CBT + Diet, CBT + Exercise + Diet), and two phases (10-week intervention-phase and 5-month follow-up phase). This is psycho-physical intervention in the form of cognitive behavior therapy, exercise regimen and diet plan for obesity and associated factors management. The selected associated factors of obesity are eating behavior, sedentary behavior, body image, and self-control. The “CBT + Exercise” intervention consists of cognitive behavior therapy (regarding obesity reduction & associated factors management) and exercise (supervised & unsupervised-home based activities). Intervention provided as a group form, participants received 10 consultations (face to face) with a clinical psychologist (weekly sessions, 70-min average time duration for 10-week intervention) for providing awareness and psychological empowerment to participants for regulating exercise in daily life routine, reducing sedentary behavior (by breakdown long sitting period, and short bouts of walking), improving body image (by focusing body parts and accepted changes, as well as trying to reduce abdomen and lower trunk) and increasing self-control (by discontinuing lazy life routine and tailoring exercise according schedule on daily basis). Further, the same “CBT + Exercise” intervention provided 10 consultations (face to face) with a physiotherapist (weekly sessions, 50-min average time duration for 10-week intervention). During consultation physiotherapist offered supervised physical exercise execution (by aerobic exercise 20min & treadmill 20min) and guided unsupervised home-based physical activities (aerobic dancing, jogging, walking; physical activity time 15-35 min goal; pedometer steps 2500-8000 goal). The repeated assessment takes place from week 1(baseline), 4, 8, and week 10th (post-intervention) as an active intervention phase, and final assessment takes place at 30th week as a 5-month follow-up phase. All assessment and sessions occurred in fitness club for all groups but in different timings and days. The “CBT + Diet” intervention consists of cognitive behavior therapy (regarding obesity reduction & associated factors management) and diet management (restriction of calories, fat, & carbohydrates intake). Intervention provided as a group form, participants received 10 consultations (face to face) with a clinical psychologist (weekly sessions, 70-min average time duration for 10-week intervention) for providing awareness and psychological empowerment to participants for regulating eating behavior (by regulating eating pattern including timing and frequency, avoid overeating, consciously eating slow and maintained normal eating behavior), reducing sedentary behavior (by breakdown long sitting period but avoid additional exercise until trial completion), improving body image (by focusing body parts and accepted changes, as well as trying to reduce abdomen and lower trunk through dieting) and increasing self-control (by controlling eating behavior). Further, the same “CBT + Diet” intervention provided 10 consultations (face to face) with a dietitian (weekly sessions, 40-min average time duration for 10-week intervention). During consultation dietitian offered diet plan (calories 2200-1200 kcal, fat 50-25 gm, and carbohydrate 250-140 gm intakes goal) according body weight and educated participants regarding balanced diet (proper diet, different diet groups, food labels, energy balanced model, calories calculator). The repeated assessment takes place from week 1(baseline), 4, 8, and week 10th (post-intervention) as an active intervention phase, and final assessment takes place at 30th week as a 5-month follow-up phase. The “CBT + Exercise + Diet” intervention consists of cognitive behavior therapy (regarding obesity reduction & associated factors management), exercise (supervised & unsupervised-home based activities), and diet management (restriction of calories, fat, & carbohydrates intake). Intervention provided as a group form, participants received 10 consultations (face to face) with a clinical psychologist (weekly sessions, 90-min average time duration for 10-week intervention) for the same purpose that described above for the “CBT + Exercise” intervention and “CBT + Diet” intervention. Further, the same “CBT + Exercise + Diet” intervention provided 10 consultations (face to face) with a physiotherapist (weekly sessions, 50-min average time duration for 10-week intervention). During consultation physiotherapist offered the same services that provided for “CBT + Exercise” intervention that discussed above. Furthermore, the same “CBT + Exercise + Diet” intervention provided 10 consultations (face to face) with a dietitian (weekly sessions, 40-min average time duration for 10-week intervention). During consultation dietitian offered the same services that provided for “CBT + Diet” intervention that discussed above. The repeated assessment takes place from week 1 (baseline), 4, 8, and week 10th (post-intervention) as an active intervention phase, and final assessment takes place at 30th week as a 5-month follow-up phase. Intervention fidelity maintained by monitoring self-report diaries on weekly basis and through continuous assessment as well as providing professional experts consultations on weekly bases (face to face).

Sponsors

The Islamia University Bahawalpur
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 36 Years
Healthy volunteers
Yes

Inclusion criteria

Participants were recruited on the basis of following inclusion criteria; 1. Health screening (no serious medical problem). 2. Body Mass Index (BMI =25.0-29.9 kg/m2) According Asian cut off point. 3. Aged between 18 and 36 years. 4. Women only (gender)

Exclusion criteria

Participants were excluded on the following criteria; 1. Health screening (serious medical problems such as Asthma, Diabetes, Heart problems etc). 2. Overage >36 or under age <18. 3. BMI less than <25, or greater than >30. 4. Unable to attend group sessions on regular basis (weekly). 5. Male (gender)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026