Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001104246
Ethics application status
Approved
Date submitted
14/06/2018
Date registered
3/07/2018
Date last updated
3/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of Psycho-Physical Intervention for obesity and weight-reduction among women- A randomized controlled trial
Scientific title
The efficacy of Psycho-Physical Intervention for obesity and associated factors among women- A randomized controlled trial
Secondary ID [1] 295094 0
None
Universal Trial Number (UTN)
U1111-1215-1717
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308158 0
Condition category
Condition code
Diet and Nutrition 307197 307197 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 301539 0
Lifestyle
Intervention code [2] 301540 0
Rehabilitation
Intervention code [3] 301541 0
Treatment: Other
Comparator / control treatment
The control group consists of knowledge evaluation (reasons for obesity) and awareness sessions or information only (regarding physical activity, diet, eating behavior, sedentary behavior, body image, & self-control). Participants received 10 consultations (face to face, group form) with a clinical psychologist (weekly sessions, 70-min average time duration for 10-week education) for providing information-only about importance of physical activity, reasons for overweight and obesity, advantages and disadvantages of sedentary behavior, balanced diet, energy expenditure and eating behavior, life style modification and body image importance, as well as advantages and disadvantages of self-control. Participants instructed to maintain normal daily life routine activities until current program sessions finished. 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.
Control group
Active

Outcomes
Primary outcome [1] 306297 0
Changes in body weight (kg) and body mass index (BMI).
Bioelectrical impedance analysis (InBody-370).
Timepoint [1] 306297 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Primary outcome [2] 306298 0
Changes in waist to hip ratio WHR (cm).
Bioelectrical impedance analysis (InBody-370) for digital measurement. For manual measurement used Stadiometer and Insertion tape then divide of waist to hip (W/ H).
Timepoint [2] 306298 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Primary outcome [3] 306299 0
Changes in percent body fat (PBF).
Bioelectrical impedance analysis (InBody-370).
Timepoint [3] 306299 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up).
Secondary outcome [1] 348100 0
Changes in physical activity-unsupervised (home based)
Self-reported diaries (physical activity time).
Pedometer for step counting.
Timepoint [1] 348100 0
Measured at week 2nd (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Secondary outcome [2] 348101 0
Changes in diet (calories, fat, carbohydrates intake).
"MyFitnessPal” application.
Self-reported diaries.
Timepoint [2] 348101 0
Measured at week 2nd (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up).
Secondary outcome [3] 348102 0
Changes in eating behavior.
Measured using the three factor eating questionnaire (TFEQ)
Timepoint [3] 348102 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Secondary outcome [4] 348104 0
Changes is sedentary behavior.
Measured using the adult sedentary behavior questionnaire (SBQ-Adults).
Timepoint [4] 348104 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Secondary outcome [5] 348105 0
Changes in body image.
Measured using multidimensional body-self relations questionnaire-appearance scale (MBSRQ-AS).
Timepoint [5] 348105 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Secondary outcome [6] 348106 0
Changes in self-control.
Measured using the brief self control scale (BSCS).
Timepoint [6] 348106 0
Measured at week 1st (baseline), 4th, 8th, 10th (post-intervention), and week 30th (5-month follow-up)
Secondary outcome [7] 348107 0
Effectiveness of cognitive behavior therapy for the current program.
Self-reported. Using 10-point numeric rating scale for "overall satisfaction or dissatisfaction with cognitive behavior therapy sessions from pre-intervention to post-intervention" where 0= "fully dissatisfied" and 10= "fully satisfied".
Timepoint [7] 348107 0
Measured at week 1st (pre-intervention) and week 10th (post-intervention).

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
36 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Conceal allocation is made through online permuted random block sizes randomization by a researcher, but not involved in participant recruitment process and assessment. The team members whom recruited potential participants according eligibility criteria were unaware, when this decision was made, to which group the participant were allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We applied permuted block randomization through online (www.randomization.com) random permuted blocks of different sizes. A randomization plan generated on the basis of I.D number by a person not involved in recruitment process as well as recruitment team and participant not aware which i.d number allocated to which group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data were analyzed in eighth key steps:
1. In the first step, preliminary analysis run for computing data normality distribution and outcomes measures differences between and within groups through boxplot.
2. In the second step basic assumptions were evaluated and satisfied before run the repeated measures ANOVA such as there was no missing data, sampling distribution was normal, homogeneity of variance and sphericity were satisfactory, as well as absence of outliers. After that primary analyses were run for computing baseline differences in primary measures (body weight, body mass index, waist-to-hip ratio, percent body fat) of all groups. Repeated measures ANOVA run for computing effect of treatment condition and time in primary measures among groups from baseline to post intervention and follow-up phase..
3. Post-hoc analyses were run to confirm the significance differences among groups.
4. In the fourth step, primary analyses were run for computing baseline differences in self-reported measures (physical activity time, pedometer steps, calories, fat, and carbohydrates intakes). Independent sample t-test was run to compute baseline differences in self-reported measures between groups according treatment conditions. Repeated measures ANOVA run for computing effect of treatment condition and time in self-monitor measures among groups from baseline to post intervention and follow-up phase.
5. In the fifth step, secondary analyses were run for computing baseline differences in associated factors (eating behavior, sedentary behavior, body image, and self-control) among groups. Repeated measures ANOVA run for computing effect of treatment condition and time in contributing factors among groups from baseline to post intervention and follow-up phase.
.
6. In the sixth step, descriptive statistics were run including mean, standard deviation and frequency distribution to compute differences of cognitive behavior therapy (CBT) effectiveness questionnaire among groups.
7. In the seventh step, one-way ANOVA run for computing CBT effectiveness differences among groups at baseline. Repeated measure ANOVA was run to compute changes in CBT effectiveness from baseline to end of treatment.
8. In the eighth final step, Pearson correlation was run for computing relationship among obesity diagnostic components (body weight, body mass index, waist-to-hip ratio, percent body fat) and obesity associated factors (eating behavior, sedentary behavior, body image, and self-control) at baseline and end of treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/11/2016
Date of last participant enrolment
Anticipated
Actual
7/01/2017
Date of last data collection
Anticipated
Actual
17/09/2017
Sample size
Target
128
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 10561 0
Pakistan
State/province [1] 10561 0
Punjab

Funding & Sponsors
Funding source category [1] 299676 0
Self funded/Unfunded
Name [1] 299676 0
Country [1] 299676 0
Primary sponsor type
University
Name
The Islamia University Bahawalpur
Address
The Islamia University Bahawalpur, Department of Applied Psychology, Baghdad ul Jadeed Campus, 63100, Bahawalpur, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 299010 0
None
Name [1] 299010 0
Address [1] 299010 0
Country [1] 299010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300575 0
IUB-Research Ethics Committee
Ethics committee address [1] 300575 0
Ethics committee country [1] 300575 0
Pakistan
Date submitted for ethics approval [1] 300575 0
02/08/2016
Approval date [1] 300575 0
18/11/2016
Ethics approval number [1] 300575 0
IUB-9872/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84102 0
Mr Muhammad Waseem Tufail
Address 84102 0
Department of Psychology & Counseling, Sultan Idris Education University, 35900 Perak, Tanjung Malim.
Country 84102 0
Malaysia
Phone 84102 0
+60-11-12467506
Fax 84102 0
Email 84102 0
[email protected]
Contact person for public queries
Name 84103 0
Dr. Muhammad Saleem
Address 84103 0
Department of Applied Psychology, The Islamia University of Bahawalpur, 63100, Baghdad Campus, Bahawalpur.
Country 84103 0
Pakistan
Phone 84103 0
+92-300-6337286
Fax 84103 0
Email 84103 0
[email protected]
Contact person for scientific queries
Name 84104 0
Dr. Rahmattullah Khan
Address 84104 0
Department of Psychology & Counseling, Sultan Idris Education University, 35900 Perak, Tanjung Malim.
Country 84104 0
Malaysia
Phone 84104 0
+60-13-3995955
Fax 84104 0
+60-154-8117583
Email 84104 0
[email protected]

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