Satiating Diet vs. Restrictive Intervention for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Must not be taking: Thyroid therapy, Sulfonylureas, Glucocorticoids, Insulin
Disqualifiers: Eating disorders, Chronic diseases, Depression, others
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
If you are taking medications that could affect your appetite or body weight, such as thyroid replacement therapy, sulfonylureas, or glucocorticoids, you will not be eligible to participate in this trial.
What data supports the effectiveness of the treatment Satiating Diet vs. Restrictive Intervention for Obesity?
Research shows that a non-restrictive satiating diet can lead to significant weight loss and improved eating behaviors in obese individuals, with lower dropout rates compared to a control diet. Additionally, personalized dietary strategies that focus on behavior change and energy intake reduction are effective for sustainable weight management.
12345Is the Satiating Diet vs. Restrictive Intervention for Obesity safe for humans?
The research does not provide specific safety data for the Satiating Diet vs. Restrictive Intervention for Obesity, but it discusses various dietary interventions for weight loss, which are generally considered safe when monitored by healthcare professionals.
678910How does the non-restrictive satiating diet treatment for obesity differ from other treatments?
The non-restrictive satiating diet is unique because it allows individuals to eat freely without strict calorie limits, focusing on a balance of higher protein and fat intake to enhance feelings of fullness, which may lead to better adherence and weight loss compared to traditional restrictive diets.
2351112Eligibility Criteria
This trial is for men and women aged 18-50 with obesity, defined by a waist circumference over 102 cm for men or over 88 cm for women, and a BMI between 30 and <40. Participants should not be on medications affecting weight or appetite, have chronic diseases, use excessive alcohol or caffeine, or be pregnant. They also shouldn't engage in high physical activity.Inclusion Criteria
Waist circumference >102 cm in men and >88 cm in women
I am between 18 and 50 years old.
My BMI is between 30 and 40.
Exclusion Criteria
I am being treated with insulin for type 2 diabetes.
I have severe symptoms of depression.
Smoking, drugs or alcohol (>2 drinks/d)
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Weight Loss Phase
Participants undergo a 6-month weight loss intervention with different strategies: non-restrictive satiating intervention, conventional restrictive intervention, or minimal healthy guidelines.
6 months
Bi-weekly visits with a dietitian
Maintenance Phase
Participants continue with a 12-month weight maintenance intervention, either continuing the non-restrictive satiating intervention or switching from a restrictive intervention.
12 months
Monthly visits with a dietitian
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if a non-restrictive satiating diet helps control appetite and maintain weight loss better than conventional diets. Over 18 months, participants follow either this diet throughout; switch from calorie restriction to the satiating diet; or follow minimal guidelines then recommended maintenance strategies.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-restrictive satiating interventionExperimental Treatment1 Intervention
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).
Group II: Conventional restrictive intervention + non-restrictive satiating interventionExperimental Treatment1 Intervention
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Group III: Minimal healthy guidelinesPlacebo Group1 Intervention
Considering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Department of Physical EducationQuébec, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
University of OttawaCollaborator
References
The efficacy of dietary fat vs. total energy restriction for weight loss. [2019]Dietary fat restriction is currently being promoted as a weight loss strategy. However, previous investigations suggest that fat restriction alone may not be more beneficial than total energy restriction for the treatment of obesity. The purpose of this project was to assess whether an energy-restricted or fat-restricted diet was more effective at promoting weight loss, improving eating behaviors, and reducing barriers to dietary adherence.
Impact of a non-restrictive satiating diet on anthropometrics, satiety responsiveness and eating behaviour traits in obese men displaying a high or a low satiety phenotype. [2017]The aim of this study was to evaluate the impact of a non-restrictive satiating diet in men displaying various degrees of satiety efficiency. In all, sixty-nine obese men aged 41·5 (sd 5·7) years were randomly assigned to a control (10-15, 55-60 and 30 % energy as protein, carbohydrate and lipid, respectively; n 34) or satiating (20-25, 45-50 and 30-35 % energy as protein, carbohydrate and lipid, respectively; n 35) diet for 16 weeks, and were classified as having a low (LSP) or high (HSP) satiety phenotype. Both diets were consumed ad libitum. Changes in body weight, BMI, percent fat mass, waist circumference, satiety responsiveness and eating behaviour traits were assessed following the intervention. Dropout rates were higher in the control diet (44·1 %) compared with the satiating diet (8·6 %). Decreases in body weight, BMI and waist circumference were significant in both groups, yet HSP individuals lost more body weight than LSP individuals (P=0·048). Decreases in % fat mass were greater in the satiating diet (LSP: -2·1 (sd 2·1) %; P
Exploring Rates of Adherence and Barriers to Time-Restricted Eating. [2023]Whilst the treatment and prevention of overweight and obesity-related disease is managed by restricting daily energy intake, long-term adherence to dietary strategies appears unsustainable. Time-restricted eating (TRE) aims to position energy intake in an eating window under 12 h per day and offers an alternative behavioral intervention, which can aid weight management and improve cardiometabolic health. Adherence to previous TRE protocols is estimated at between 63 and 100%, although the accuracy of reporting is unclear. This study therefore aimed to provide an objective, subjective, and qualitative overview of adherence to a prescribed TRE protocol, and to identify any potential barriers affecting adherence. Adherence after 5 weeks of TRE was estimated at ~63% based on continuous glucose monitoring data when compared with time-stamped diet diaries. Subjective participant responses reported adherence at an average of ~61% per week. Barriers to adopting TRE, including work schedules, social events, and family life, were identified by participants during qualitative interviews. The findings of this study suggest that the development of personalized TRE protocols may help to navigate the barriers to adherence leading to improved health-related outcomes.
The Effectiveness of Nutritional Strategies in the Treatment and Management of Obesity: A Systematic Review. [2023]Obesity, a condition primarily resulting from positive energy balance, has become a significant global health concern. Numerous studies have demonstrated that obesity is a major risk factor for various illnesses, including different types of cancer, coronary heart disease, sleep apnea, CV stroke, type II diabetes mellitus, etc. To effectively address this issue, prevention and treatment approaches to manage body weight are crucial. There are several evidence-based approaches available for the treatment and management of obesity, taking into account factors such as body mass index classification, individual weight history, and existing comorbidities. To facilitate successful obesity treatment and management, there are pragmatic approaches and tools available, including the reduction of energy density, portion control, and diet quality enhancement. These approaches encompass the use of medications, lifestyle interventions, bariatric surgery, and formula diets. Regardless of the specific method employed, behavior change, reduction of energy intake, and increased energy expenditure are integral components for successful treatment and management of obesity. These measures allow patients to personalize and customize their dietary patterns, leading to effective and sustainable weight reduction. Incorporating physical activities and self-monitoring of individual diets are effective techniques for promoting behavior change in obesity and weight management. The main objective of this systematic review is to evaluate the effectiveness of dietary/nutritional interventions in the treatment and management of obesity through provision of valuable insights into the effectiveness of such nutritional strategies. To attain this, a comprehensive analysis of various dietary approaches and their impacts on weight will be conducted.
Randomized evaluation of a low fat ad libitum carbohydrate diet for weight reduction. [2014]Restricting dietary fat intake while consuming carbohydrates ad libitum has recently been promoted as a weight loss regimen. Sixty subjects (52 females and eight males) were randomized to low fat ad libitum carbohydrate (low-fat) or low fat with caloric restriction (low-calorie) behaviour modification treatments. Forty-nine subjects completed the 16-20 week programme. Subjects in both groups reported averaging over five exercise sessions per week during treatment. The low-calorie group lost significantly more weight (males 11.8 kg, s.d. 6.4; females 8.2 kg, s.d. 4.2) than the low-fat group (males 8.0 kg, s.d. 1.3; females 3.9 kg, s.d. 3.7). Both groups of subjects lost similar amounts of lean body mass. There was significantly greater loss of body fat in the low-calorie group. A slight reduction in RMR, adjusted for changes in lean body mass, was observed in both groups. Fat intake was reduced from 90 to 30 g per day. Subjects in both groups reduced their total energy intake with the low-calorie group consuming fewer calories per day than the low-fat group. Both groups showed significant and equivalent improvements in eating habits based on microanalysis of eating diaries. Eating in social situations and emotional eating, however, continued to cause adherence problems during treatment for both groups. Follow-up data collected 9-12 months after completion of treatment on 65% of the subjects completing the study showed no significant difference between the two groups in weight losses from baseline (low-fat group 2.6 kg; low-calorie group 5.5 kg).
The effect of time of eating on cardiometabolic risk in primary and secondary prevention of cardiovascular disease. [2023]Continuous energy restriction is currently considered the first-line dietary therapy for weight loss in individuals with obesity. Recently, interventions which alter the eating window and time of eating occasions have been explored as means to achieve weight loss and other cardiometabolic improvements such as a reduction in blood pressure, glycaemia, lipids and inflammation. It is unknown, however, whether these changes result from unintentional energy restriction or from other mechanisms such as the alignment of nutrient intake with the internal circadian clock. Even less is known regarding the safety and efficacy of these interventions in individuals with established chronic noncommunicable disease states, such as cardiovascular disease. This review examines the effects of interventions which alter both eating window and time of eating occasions on weight and other cardiometabolic risk factors in both healthy participants and those with established cardiovascular disease. We then summarise the state of existing knowledge and explore future directions of study.
Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]The current obesity epidemic is staggering in terms of its magnitude and public health impact. Current guidelines recommend continuous energy restriction (CER) along with a comprehensive lifestyle intervention as the cornerstone of obesity treatment, yet this approach produces modest weight loss on average. Recently, there has been increased interest in identifying alternative dietary weight loss strategies that involve restricting energy intake to certain periods of the day or prolonging the fasting interval between meals (i.e., intermittent energy restriction, IER). These strategies include intermittent fasting (IMF; >60% energy restriction on 2-3 days per week, or on alternate days) and time-restricted feeding (TRF; limiting the daily period of food intake to 8-10 h or less on most days of the week). Here, we summarize the current evidence for IER regimens as treatments for overweight and obesity. Specifically, we review randomized trials of ≥8 weeks in duration performed in adults with overweight or obesity (BMI ≥ 25 kg/m2) in which an IER paradigm (IMF or TRF) was compared to CER, with the primary outcome being weight loss. Overall, the available evidence suggests that IER paradigms produce equivalent weight loss when compared to CER, with 9 out of 11 studies reviewed showing no differences between groups in weight or body fat loss.
Dietary treatments of obesity. [2019]Dietary treatment of obesity is based on one or another of two premises: that the obese eat too much or that they eat the wrong things. The first is a tautology lacking explanatory power. The second is a meaningful and promising hypothesis but has yet to be effectively applied. At present, virtually all outpatient treatments of obesity, including behavior modification, are based on the first premise and consist of strategies for reducing the subject's caloric intake. Most such interventions produce short-term weight loss. Regain after the end of treatment remains the usual outcome. A survey of studies published in the period 1977-1986 and reporting on dietary or behavioral treatment of obesity reveals that the maximum percentage of body weight lost is, on average, 8.5 percent--no different from the value, 8.9%, in similar studies from 1966-1976, as reviewed by Wing and Jeffery. The principal determinant of success in such programs appears to be the intake weight of the subjects: the higher the intake weight, the more successful the intervention will appear to be. The goals and research methods of studies on dietary treatments for obesity are overdue for ethical as well as scientific reevaluation. The same may be said for the numerous programs providing such treatment outside the context of research.
Calorie restriction is more effective for obesity treatment than dietary fat restriction. [2018]Recent evidence suggests that dietary fat intake may be more strongly associated than total energy intake to the development and maintenance of obesity. The objective of this study was to determine whether dietary fat restriction would promote more favorable changes in body weight, body composition, resting metabolic rate (RMR), eating behavior, and dietary adherence than calorie restriction. Sixty-five obese women and 15 obese men were recruited and randomly assigned to calorie restriction (1000-1200 kcal/day) or fat restriction (22-26 g/day). Subjects participated in a 24-week behavioral weight loss program. Forty-eight subjects completed assessments at all four time points-baseline and 6, 12, and 18 months. Weight loss was significantly greater in the low calorie (LC) group (-11.2 versus -6.1 kg, p
Mindful eating for weight loss in women with obesity: a randomised controlled trial. [2023]Mindful eating (ME) has been linked to improvement in binge eating disorder, but this approach in obesity management has shown conflicting results. Our aim was to assess the effect of ME associated with moderate energy restriction (MER) on weight loss in women with obesity. Metabolic parameters, dietary assessment, eating behaviour, depression, anxiety and stress were also evaluated. A total of 138 women with obesity were randomly assigned to three intervention groups: ME associated with MER (ME + MER), MER and ME, and they were followed up monthly for 6 months. ME + MER joined seven monthly mindfulness-based intervention group sessions each lasting 90 min and received an individualised food plan with MER (deficit of 2092 kJ/d - 500 kcal/d). MER received an individualised food plan with MER (deficit of 2092 kJ/d - 500 kcal/d), and ME joined seven monthly mindfulness-based intervention group sessions each lasting 90 min. Seventy patients completed the intervention. Weight loss was significant, but no statistically significant difference was found between the groups. There was a greater reduction in uncontrolled eating in the ME group than in the MER group and a greater reduction in emotional eating in the ME group than in both the MER and the ME + MER groups. No statistically significant differences were found in the other variables evaluated between groups. The association between ME with energy restriction did not promote greater weight loss than ME or MER.
Feasibility and outcomes from using a commitment device and text message reminders to increase adherence to time-restricted eating: A randomized trial. [2023]Obesity is strongly associated with cardiovascular disease, particularly through its effects on blood pressure. Though maintaining a negative caloric balance leads to weight loss, many patients struggle to adhere to low calorie diets over the long term. Time-restricted eating, a subtype of intermittent fasting (IF), may be an easier dietary pattern for patients to initiate and maintain. We tested the feasibility of a bidirectional texting strategy to help patients with obesity and hypertension initiate and maintain time-restricted eating, and whether a commitment device, a pledge to behave in a certain way in the future while making nonadherence costlier, would increase adherence beyond bidirectional texting.
Assessing the three types of dieting in the Three-Factor Model of dieting. The Dieting and Weight History Questionnaire. [2022]The construct of attempted eating restriction has been measured in a number of ways in recent years. The Three-Factor Model of Dieting suggests that dieting can be subdivided into three types: (1) frequency of past dieting and overeating (i.e., history of dieting), (2) current dieting to lose weight, and (3) weight suppression, or the difference between an individual's current weight and his or her highest previous weight. The purpose of this paper is to (1) describe the Dieting and Weight History Questionnaire (DWHQ), a measure that we have used for many years to assess these three dimensions of dieting; (2) provide some recent examples of published research on each type of dieting; (3) discuss some of the nuances of assessing these dieting types; and (4) suggest directions for future research.