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Effect of Combination of Behavioural Intervention and Nutrition Education with Brown Rice (COMBINE-BROWN) Weight Loss Program on Body Composition and Oxidative Stress among Overweight and Obese Adults.

Effect of Combination of Behavioural Intervention and Nutrition Education with Brown Rice (COMBINE-BROWN) Weight Loss Program on Body Composition and Oxidative Stress among Overweight and Obese Adults.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001159640
Acronym
COMBINE-BROWN clinical weight loss intervention
Enrollment
103
Registered
2023-11-08
Start date
2017-06-01
Completion date
2019-03-28
Last updated
2023-11-13

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

Conditions

None listed

Brief summary

Rice is a staple food for nearly half of the human population around the world, especially Asian countries. In Malaysia, the adults consumes the average of 2 and half plates of rice twice daily (Norimah et al. 2008). Previous focus group studies indicated that brown rice is less popular and not well-accepted as daily consumption compared to white rice had due to its brownish appearance and harder texture (Sudha et al. 2013 and Adebamowo et al., 2017). However, brown rice consumption has shown beneficial impacts on weight loss, improving metabolic syndrome, and antioxidant levels in a few randomised trials, such as China (Zhang et al. 2011) and India (Malik et al., 2019). These studies showed inconsistent results due to different study designs and cultural pratices. The current study was a pilot study to assess the impacts of brown rice among overweight and obese Malay population in Malaysia in a three months quasi-experimental behavioral weight loss study. The research hypothesis of the study: there are significant improvements in body weight, body fat percentage, and antioxidants level between the control group and intervention group after 12-week of participating in a COMBINE-BROWN clinical weight loss program among overweight and obese adults.

Interventions

The weight loss study incorporates nutrition education, exercise, and behavioral modification approach, with brown rice consumption. The study involves a 12-week intervention phase and another 12 week maintenance phase. The participants are allocated into two groups, the intervention and control group. The intervention group receives 12-week behavioral weight loss intervention study, with health education on brown rice and incorporation of brown rice as daily diet regimen. The study is conducted

The weight loss study incorporates nutrition education, exercise, and behavioral modification approach, with brown rice consumption. The study involves a 12-week intervention phase and another 12 week maintenance phase. The participants are allocated into two groups, the intervention and control group. The intervention group receives 12-week behavioral weight loss intervention study, with health education on brown rice and incorporation of brown rice as daily diet regimen. The study is conducted in Universiti Sains Malaysia, Kelantan, Malaysia. It must be emphasised that the weekly nutritional, behavioural, and exercise sessions were conducted together in the same session. Furthermore, the group sessions were conducted when there was a requirement to conduct an in-depth discussion and encouragement of peer support among the participants; meanwhile, individual sessions were conducted when there was a need for individual dietary advice or health concern. The experienced nutritionists and dietitians deliver the nutrition education modules, which will be conducted approximately one hour session for 12 weeks, using the local languages with simple sentences. These modules included general nutrition knowledge, based on Malaysian Dietary Guidelines. The healthy regimen such as Malaysian Food Pyramid and Malaysian Healthy Plate were introduced to the participants as a guideline for healthy diet (MOH, 2021). The twelves modules of the Nutrition Education Modules include Introduction of Obesity and Risk of Obesity, Obesity and Energy Balance, Food Pyramid, Food Serving Size, Carbohydrate, Fat and Protein, Weight Changes Challenges, Food Labelling, Fibre, Vitamins and Minerals, Weight Management, and Total Weight Changes. A total of 12 classes are scheduled weekly during the intervention period, using face-to-face approach. For the intervention group, the participants are prescribed with seven cups of brown rice every week and they are required to consume at least one serving of brown rice each day. The exercise components are delivered weekly by fitness instructors in groups. The exercise regimen includes brisk walking (approximately one hour), aerobic exercise (30 minutes), and dumbbell resistance exercise (30 minutes) (Matsuo and Suzuki, 1999) for 12 classes over 12 weeks intervention period. The intensity is gradually increased from low to intermediate, with about 33 in each groups. The intensity of physical activity level will be assessed using Malay version of the International Physical Activity Questionnaires (IPAQ-BM) (IPAQ, 2004). The behavioral modification approach includes goal-monitoring, individual and group counselling, self-monitoring, and problem solving (Burgess et al, 2017). For the maintenance phase, the participants are required to continue the behavioral weight loss regimen for another 12 week after the intervention. The food diary is distributed to each participants to record their daily food intakes and served as self-monitoring purposes. For individual and group counselling, the recorded food diary will be discussed individually or in group with the nutritionists or dietitians. The participants will be advised to change the type and amount of their food intakes. Moreover, for problem solving, the problem encountered and the possible solution during the weight loss will be also discussed individually or in groups with the researchers. The discussion session will be conducted approximately one hour for 12 classes over 12 weeks intervention period. The classes will be conducted using face-to-face method. The Malay version of Impact Weight of Quality of Life-LITE (Kolotkin, 2017) will be used to assess the impact of weight on quality of life among the participants. The session attendance checklist will be used to assess the attendance of the participants in the behavioural weight loss program, which integrates nutrition education modules, exercise regimen, and behavioural weight loss approach.

Sponsors

Universiti Sains Malaysia (USM)
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy adults 2. BMI similar or more than 27 kg/m2 3. Able to do exercise or walking without aid 4, Undergo medical examination 5. Willing to consume brown rice for three months

Exclusion criteria

1. Diagnosed as mental illness 2. Pregnant 3. Exclude those who participate in other weight loss program during the study period

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026