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Instrumentalization of dieting in the management of obesity: a randomized controlled trial

Instrumentalization of dieting in the management of obesity: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031209
Enrollment
Unknown
Registered
2020-03-24
Start date
2020-04-15
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

obesity

Interventions

experimental group:A restricted daily energy intake based on a balanced diet will be prescribed between 1200kcal and 1500kcal for women and between 1500kcal and 1800kcal for men.
experimental group:Participants will be permitted to eat breakfast as usual with necessary dietary advices from a dietician. The daily energy intake prescribed with the exception of the breakfast ener
experimental group:Participants will be asked to consume prescribed types as well as recommended portion sizes of staple foods for both lunch and dinner.
experimental group:Participants will be asked to consume a recommended portion size of meat and need to eat an egg, 200g fruits, 10g nuts, less than 30g cooking oil, and drink 300ml milk daily.
experimental group:With the exception of the foods mentioned above, participants will be asked to consumed 5 foods with the food density factors (FDF) less than 0.5kcal/g, no more than 2 foods with th
experimental group:Participants will be asked to adhere to the principles mentioned above daily and to record which principles they are incapable of adherence. Participants will be also asked to reco
experimental group:Participants will be asked to do physical exercises 30 minutes with moderate intensity for not less than 5 days per week.
experimental group:Participants will be asked to participate in 6-session core curriculums as a group during the first month and a half of the study period (once a week). Each curriculum will last bet
experimental group:Participants will be asked to participate in a total of 13 times face to face interviews with a dietician.
control group:A restricted daily energy intake based on a balanced diet will be

Sponsors

Yanan Hospital Affiliated to Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: A volunteer must: 1) Live in Kunming; 2) Be aged between 18 to 60 years; 3) Have a Body Mass Index (BMI) between 28 to 40kg/m2; 4) Have time to participate in both face to face interviews and core curriculums during the study period; 5) Meet diagnostic criteria for the pre-diabetics but having not begun any drug therapy are preferred.

Exclusion criteria

Exclusion criteria: An individual if he/she: 1) Has the risks of developing malnutrition and endocrine disorders; 2) Had undertaken a systemic hormone therapy within the previous 2 years; 3) Had an experience of any weight management program, including bariatric surgery and pharmaceutical weight loss, within the previous 1 year; 4) Has a significant eating disorder such as bulimia nervosa or binge eating; 5) Has frequently used dietary supplements in large quantities or use drugs which limiting specific foods consumption; 6) Has a limitation on physical exercises due to several conditions, including osteoarticular disease, cardiovascular disease, cognitive disorder and mental diseases; 7) Is pregnant or lactating; 8) Has clinically diagnosed metabolic syndrome and have begun a medication treatment.

Design outcomes

Primary

MeasureTime frame
weight;

Secondary

MeasureTime frame
The Diet Satisfaction Questionnaire scores;

Countries

China

Contacts

Public ContactXianjun Yang

Yan'an Hospital Affiliated to Kunming Medical University

phillins@163.com+86 18608710680

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026