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临床试验/NCT05141526
NCT05141526招募中不适用

Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?

Laval University2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
234
试验地点
2
主要终点
Energy intake

研究概览

简要总结

The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss [Phase 1 (P1): 6 months] and maintenance trial [Phase 2 (P2): 12 months] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding participants is not possible due to the nature of the interventions. Individuals independent from the study and blinded to groups (e.g. statistician), will conduct the randomization and analyses while a research assistant, instructed not to discuss treatments with participants, will conduct the testing sessions.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individuals with a BMI ≥30 and <40 kg/m2
  • aged between 18-50 years
  • waist circumference >102 cm in men and >88 cm in women.

排除标准

  • taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
  • being treated with insulin for type 2 diabetes
  • large body weight fluctuations (>4 kg over last two months)
  • characterized by high restraint behaviour (score >12, measured with the TFEQ)
  • history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
  • performing >150 min of moderate-vigorous intensity physical activity/week
  • use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (>2 drinks/d)
  • consumption of >5 cups of coffee/d
  • (pre)menopausal or pregnant women
  • diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers)
  • food allergies/intolerances to ingredients/foods in the satiating intervention
  • having a pacemaker (for fMRI)
  • taking sedatives or sleeping pills
  • symptoms of depression (>20 on the BDI).

结局指标

主要结局

Energy intake

时间窗: 6 months

measured at an ad libitum meal in kilocalories

Body weight

时间窗: 6 months

Body weight loss (kg) after Phases 1 and 2

Body composition

时间窗: 6 months

Body fat (using dual x-ray absorptiometry)

Hunger/Satiety

时间窗: 6 months

using a visual analogue scale and measured in mm

次要结局

  • Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)(18 months)
  • Diet satisfaction(18 months)
  • Stress(18 months)
  • Anxiety(18 months)
  • Depression Symptoms(18 months)
  • Eating Behaviours(18 months)
  • Blood pressure(18 months)
  • neurobehavioural variables(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicky Drapeau

Principal Investigator

Laval University

研究点 (2)

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